câu hỏi avcn3

WNL
If a function is ______ (Within Normal Limits), it is operating in a normal range.
XR
An X-ray is a visual image of all or part of the body acquired with special equipment
using electromagnetic radiation to see bones and other internal aspects of the body.
BP
(Blood Pressure) is the force exerted by circulating blood on the walls of blood
vessels. Lt is a vital sign that medical professionals use to determine whether body
systems are operating as they should.
c/o
If a patient ______ (complains of) something, he or she describes symptoms that are
painful or uncomfortable.
Dx
(Diagnosis) is the positive identification of a patient's disease or ailment.
HR
(Heart Rate) is the frequency with which a person's heart beats in a given amount of
time. It is usually expressed in beats per minute.
HTN
(hypertension) is having blood pressure that is higher than normal.
o/e
If something is found ______ (on examination), it was discovered during an exam.
Rx
(treatment/ prescription) is the specific drug or course of action prescribed to treat a
patient's medical condition.
SOB
(Short of Breath) is a condition in which a patient finds it more difficult to breathe
than usual.
T
(temperature) is a quantitative measurement of heat within the body. It is can be used,
in part, to gauge whether the body is operating normally.
cubic centimeter (cc)

a unit of volume equal to a cube whose sides are equal to one centimeter.
drop (gtt)
a unit of liquid volume equal to the amount of liquid which comes from a dropper, or
about 1/12th of a milliliter.
gram (g)
a unit of mass which is equal to one-thousandth of a kilogram,
gtt
Drops of liquid administered to the eye.
microgram (mcg)
a unit of mass equal to one millionth of a gram.
milliequivalent (mEq)
1/1000th the weight of the minor component of a chemical solution dissolved in the
major component.
milligram (mg)
A unit of mass equal to one thousandth of a gram.
milliliter (ml)
A unit of liquid volume equal to one thousandth of a liter and equal to one cubic
centimeter.
ounce (oz)
A unit of weight equal to 1/16th of a pound.
tablespoonful (Tbsp)
A measure of volume equal to the amount a standard tablespoon can hold or about
three teaspoons.
teaspoonful (tsp)
A measure of volume equal to the amount a standard teaspoon can hold, or almost
five milliliters.
administer
To give medicine to a patient.
dosage
the correct amount and frequency of medicine to give to a person.
I.V.
An intravenous injection is a method of administering medicine into a vein using a
syringe, often over a long period of time.
IM
(intramuscular injection) A medicine that is injected into a muscle with a syringe.
P.0.
If medicine is given ______ (by mouth), it is taken orally, or through the mouth.
P.R.
If a medicine is given ______(per rectum), it is taken through the rectum.
route of administration
The path by which a medicine is taken into the body.
SQ
(subcutaneous) A medicine that is injected into the fatty layer under the skin with a
syringe.
SL
(sublingual) Medicine that is given beneath the tongue.
topical
Medicine is applied to a certain part of the surface of the body.
complaint
A(n) ______ is pain or illness reported by a patient.
onset
A(n) ______ is the start or first instance of something.
cold
A(n) ______ is an illness that can cause coughing, a runny nose, and a sore throat.
wheeze
To ______ is to breathe with difficulty in a noisy manner.
ac
A medication that is taken before meals.
BID
If a medication that is given twice per day.
pc
Medication that is given after meals.
PRN
Medication that is given as needed.
qh
Medication that is given every hour.
qhs
Medication that is given at bedtime.
QID
Medication that is given four times per day.
QOD
Medication that is given every other day.
stat
Medication that is given immediately.
TID
Medication that is given three times per day.
allergy
A(n) ______ is a medical condition that causes a reaction or illness when someone
comes in contact with a particular substance.
current
If something is ______, it is happening at the present time.
data
______ is a collection of information.
family medical history

A(n) ______ is a record of the medical conditions of a patient's family that might
affect the patient's health.
history of
If someone has a ______ something, he or she has experienced it regularly or
repeatedly.
past medical history

A(n) ______ (PMH) is a patient's record of previous illnesses, procedures, and other
medical details.
procedure
A(n) ______ is a medical treatment performed by a doctor or surgeon.
social history
A(n) ______ is a patient's record of lifestyle and personal details, such as occupation
and marital status.
cough
To ______ is to force air loudly through the throat because of an illness or throat
irritation.
fever
A(n) ______ is an illness that causes body temperature to rise,
flu
______ is a viral illness that can cause fevers, aches, and wheezing,
headache
A(n) ______ is a pain felt in the head.
muscle ache
A(n) ______ is a pain felt in the muscles.
runny
If something is ______, it has liquid flowing or leaking out of it.
symptom
A(n) ______ is a feeling or physical change that indicates illness.
throb
To ______ is to have pain that comes and goes very quickly.
affect
To ______ something such as mood is to bring about a change in it.
auscultation
______ is the examination of something by listening with or without an instrument
such as a stethoscope.
body language
______ is the conveyance of information about a person's physiological or emotional
state by the way he or she moves.
evaluate
To ______ something is to determine the qualities of its condition or state.
inspection
A(n) ______ is an organized examination of a patient's physiological state as
compared to what is understood to be normal.
observation
A(n) ______ is something that someone notices, or the act of noticing something.
palpation
______ is the examination of something by touch.
percussion
______ is the act of tapping on an area of the body such as the chest or abdomen to
determine the condition of the underlying bone or tissues.
pulse
A(n) ______ is a measure of heartbeats in a given period of time. One way to take
this measurement is to place the fingers over a major artery in the neck, wrist, or
other location and press them against a bone to feel the palpations of the heart as
blood moves through the artery.
vital signs
______ are statistical measures of essential body functions such as temperature, pulse
rate, blood pressure, and respiration.
albumin
______ is a type of protein found in the body.
biopsy
A(n) ______ is a medical procedure in which a piece of tissue is removed and
examined to help determine an illness.
blood pressure
______ is a measure of the pressure with which blood moves through the body.
blood urea nitrogen test

A ______ (BUN) test is a test to determine the amount of urea nitrogen in the blood.
chronic kidney disease

______ (CKD) is a medical condition in which a person loses kidney function over
time.
creatinine
______ is a waste product found in blood that the kidney usually removes.
glomerular filtration rate test

A ______ (GFR) test is a test to determine how much kidney function a person has.
pathology report
A(n) ______ is a report that discusses what was found after cells and tissue were
examined.
renal
If something is ______, it is related to the kidneys.
urinalysis
A(n) ______ is a test that examines a urine sample.
CT scan
A(n) ______ is a form of medical imaging that uses many two-dimensional X-rays to
create a three-dimensional image of an object.
electrocardiogram
A(n) ______ (ECG)is a measurement of the electrical activity of the heart over a
period of time.
endoscope
A(n) ______ is a thin, tubular instrument used to examine the inside of an organ or
body cavity.
feed
To _____ an endoscopic tube is to insert it into the body in order to take internal
pictures,
gel
______ is a semi-solid substance placed between the patient's skin and an ultrasound
probe.
medical imaging
______ is the process of creating pictures of the human body for the purpose of
diagnosing and treating medical problems.
magnetic resonance imaging

A(n) ______ (MRI) is a medical imaging technique that uses magnetic forces on
atoms to produce an image of the body.
radiography
______ is the use of x-rays to view images of the internal human body.
ultrasound
A(n) ______ is a medical imaging technique that uses the reflection of sound waves
to produce an image of the body.
x-ray
A(n) ______ is a form of radiation that can be used to take pictures of the internal
human body
advertisement
We will need to fill the position of clinical trial manager shortly. I'd appreciate it if
you could write up a job _______ with the input below and place it in the
pharmaceutical journal we normally use.
Clinical Affairs
__________ department tests or organizes testing on live subjects, and makes sure
that the drugs are safe and effective for the patients.
compound
We _______ the raw materials into drugs, package them, and put in the leaflets for
the patients.
drug authority
We compile the drug documentation and send it to the regulatory _______ so we can
get authorization to market the product.
drug documentation
We compile the _________ and send it to the regulatory drug authorities so we can
effective
We test or organize testing on live subjects and make sure that our drugs are safe and
______ for the patients.
Ingredient
__________is a substance in a drug.
market
Regulatory affairs department compiles the drug documentation and submits it to the
drug regulatory authorities so the company can get authorization to _____the product
Marketing and Sales

__________ department plans the promotion and distribution of drugs which will be
launched, and makes decisions about the packaging or tablet colour of new products.
Production
__________ department compounds the raw materials into drugs, packages them, and
puts in the leaflets for the patients.
promotion
The marketing department plans the _____ and distribution of drugs which will be
launched, and make decisions about the packaging or tablet colour of new products
Quality Assurance (QA)

__________ department ensures that products meet the standards which the law
requires, and contain the active ingredients advertised.
Regulatory Affairs
__________ department compiles the drug documentation and submits it to the drug
regulatory authorities so the company can get authorization to market the product.
Research and Development (R&D)

__________ department finds new substances to make new drug formulations or
changes existing dosage forms, for example, from tablets to capsules.
Analgesic
__________ is a medication to reduce or eliminate pain.
apply for
We plan to launch all of these products in Europe first and to ______ food and drug
administration (FDA) approval in the US the following year.
Colleague
__________ is someone you work with; a co-worker
conclusion
Since the ______ of our successful feasibility study, we have also obtained very
encouraging preclinical data (= end)
encouraging
Since the conclusion of our successful feasibility study, we have also obtained very
_____ preclinical data.
launch
We plan to ______ our new drug in Europe first and to apply for Food and Drug
Administration (FDA) approval in the US the following year.
Liaise
When people __________ with another, they work together and keep each other
informed about what is happening.
marketing claim
As far as Marketing is concerned, Carole Marks will be flying in from France. She'll
give us more information on the ______(s) and a target patient profile.
memo
A(n) ______ is a short official note that is sent by one person to another within the
same company or organization.
on board
Project members from Marketing, Production, and Clinical Affairs are already
______
pipeline
Pharmaceutical products in the__________ are future drugs, not yet on the market.
Preclinical data
__________ is the information about a medication that is assessed before clinical
trials.
Prescription
__________drug is the medicine bought in a pharmacy and requiring a written note
from the doctor.
determine
Feasibility study is an investigation to _____ the advantages, practicality, and
profitability of a proposed project.
Feasibility study
__________ is an investigation to determine the advantages, practicality, and
investigation
Feasibility study is an ______ to determine the advantages, practicality, and
profitability of a proposed project
powder
_____ a dry substance in the form of very small grains.
practicality
Feasibility study is an investigation to determine the advantages, _______, and
profitability
Feasibility study is an investigation to determine the advantages, practicality, and
_____ of a proposed project.
Clinical research associate

__________ performs clinical trials. __________ must also summarize, interpret and
process clinical data.
cross-functional
A project manager co-ordinates and manages the ______ teams that develop and
launch a new product.
deadline
________a date or time by which you have to do or complete something.
Medical writer
It's the __________ job to research, write, and edit clinical and study reports before
the pharmaceutical company submits them to regulatory authorities.
medication
I collect drug safety information about patients on our _______(s).
meet requirements
I operate complex scientific instruments and perform tests to determine whether
ingredients in liquids, powders, or tablets ______.
oily
Ointment is a(n) _____ substance like a cream
Ointment
__________ is an oily substance like a cream.
Packaging technician
___________'s job is to make sure that suitable, clean containers are used to get the
product from the company to the patient.
Pharmacovigilance manager
A __________ collects drug safety information after approval and reports any serious
adverse events to the health authorities.
production line
According to European law, a qualified person is responsible for the quality of each
product that leaves the ______.
Project manager
A __________ co-ordinates and manages the cross-functional teams that develop and
launch a drug.
Qualified person
A __________ is personally responsible for the quality of each product that leaves
the production line. A __________ must manage all the processes in production, QA,
and the labs to make sure SOPs are followed.
Health regulations
__________ are rules or laws about health.
adverse
Pharmaceutical companies must report serious ______events to the health authorities.
develop
Formulation scientists _____ pharmaceutical dosage forms.
Formulation scientist
A __________ develops pharmaceutical dosage forms.
health authority
Pharmaceutical companies must report serious adverse events to the ______.
Laboratory technician
__________ operates complex scientific instruments and performs tests to determine
whether ingredients in liquids, powders, or tablets meet requirements.
operate
I _____ complex scientific instruments and perform tests to determine whether
ingredients in liquids, powders, or tablets meet requirements.
pharmaceutical
Formulation scientists develop ______ dosage forms.
assigned to
I am the clinical trial manager ______ this project and am supported by two clinical
research associates who will work with test centres in northern Italy and in Slovenia
clinical trial manager

A _______ is a key position in the management of clinical trials. He is responsible
for managing the clinical trial process by implementing effective strategies for his/her
organization.
conceptual design
I was involved in the initial ______ phase, the planning and building of our new
pharmaceutical facility in Shanghai, and now I am the plant manager.
degree
I received my master's ______ at New York University and licence to practise
pharmacy in the United States
deliverables
By the end of the meeting I hope we will have come up with _______ for getting the
project off the ground and a full to do list.
expertise
I would like you to introduce yourselves and say something about your professional
background, area of _______.
licence
Before they become fully qualified, pharmacists in the US have to take an
examination to get a _____ to practise pharmacy.
methodology
I did research on clinical ________.
B.S.
__________ stands for bachelor's degree.
BSc
__________ stands for bachelor of science degree.
MS
__________ stands for master's degree.
MSc
__________ stands for master of science degree.
cost estimate
Charley is to describe the technical equipment needed with a ________ by the end of
the month.
finalize
With your input, I'll be able to _____ the timelines for planning and implementation
and decide on milestones before our next meeting.
milestone
With your input, I'll be able to finalize the timelines for planning and implementation
and decide on ______(s) before our next meeting.
accurate
You need to be able to write scientifically and technically _____ protocols in English.
analytical testing
CRO is searching for omeone to co-ordinate and perform _______ for stability
studies of new products.
clinical research organization (CRO)
_______ is an organization that provides support to the pharmaceutical,
biotechnology, and medical device industries in the form of research services
outsourced on a contract basis.
anti-depressant
Unlike in many countries , you'll also find many cheerful, bright coloured ads in
magazines, which promote ______ and other prescription drugs in the US.
cheerful
Unlike in many countries, you'll also find many ______, bright coloured ads in
magazines, which promote anti-depressants and other prescription drugs in the US.
considerably
In Europe, the strength of medicine varies ______ depending on what health
authorities allow.
consultant
_______ is someone whose job is to give advice on a particular subject.
cough
In Russia, we prefer to buy over-the-counter products, like cold remedies or ______
syrup, from people in pharmacies wearing white lab coats
cough syrup
In Russia, we prefer to buy over-the-counter products, like cold remedies or _____,
from people in pharmacies wearing white lab coats.
Cross-cultural
__________ means involving two or more different cultures.
cure
In France, medicines should not only ______ a disease, but also look fresh and
interesting.
custom
Some companies are successful at marketing their drugs all over the world without
making any major changes to them. Others have different formulations, advertising,
and packaging in each country, due to differences in ______(s) and laws.
imperfection
Quality is important all over the world, but in Japan we take it one step further. We
will reject a whole shipment of drugs if we find the smallest scratch or ______ in one
single package, even if it makes no difference to the product at all.
packaging
______ is a material used to wrap or protect good that are sold in stores
remedy
In Russia, we prefer to buy over-the-counter products, like cold _____ or cough
syrup, from people in pharmacies wearing white lab coats.
Self-medicate
__________ means to take medicine without consulting a physician.
Subsidiary
A __________ is a company which is part of a larger and more important company.
beneficial effect
Research is the process of testing chemical compounds, with the goal of finding a
substance which has a ______ on a targeted disease.
carry forward
Drug development is the process of ________ scientific discoveries made during the
research process, with the goal of producing a marketable drug.
Clinical trial
__________ is a scientific study designed to systematically test a medical
intervention in humans.
Development
__________ is the process of carrying forward scientific discoveries made during the
research process, with the goal of producing a marketable drug
discovery
In the fields of medicine, biotechnology and pharmacology, drug ______ is the
process by which new candidate medications are discovered.
Research
__________ is the process of testing chemical compounds, with the goal of finding a
substance which has a beneficial effect on a targeted disease.
breakthrough
Scientists have made a major ______ in the treatment of cancer.
chew
When you ______ food, you use your teeth to break it up in your mouth so that it
becomes easier to swallow.
New chemical entity

__________ is a unique, pharmacologically active product that has never previously
been synthesized or used to treat disease.
Obtainable
Mensamint is a new dosage form of Mensadent ( _________ with plysician's
prescription only)
occasionally
Mensamint is a new dosage form of Mensadent. Known side effects often include
loss of sleep if taken in the late afternoon or evening. ______ (now and then ), an
increase in blood pressure may occur.
occur
loss of sleep if taken in the late afternoon or evening. Occasionally, an increase in
blood pressure may _____.
palpitations
When someone has _______, their heart beats very fast in an irregular way.
(conditions of heart racing.)
Bioavailability
__________ is the proportion of a drug or other substance which enters the
circulation when introduced into the body and so is able to have an active effect.
Chewable tablet
__________ is chewed prior to swallowing. It is designed for administration to
children e.g. vitamin products.
drug administration
We will have to test the bioavailability to be able to calculate dosages for non-
intravenous routes of _____ for this NCE.
harmful
When substances are taken with alcohol or antibiotics, their chemical form could
change and even cause ______ side effects.
antidote
The science of poisons, including their source, chemical composition, action, tests ,
and even their _____(s) , is what we call Toxicology
Chemist
__________ is an expert in chemistry. In the UK, this word is also used for the
person who prepares and sells medicine, also known as a pharmacist in the US.
composition
Toxicology is the science of poisons, including their source, chemical _______,
action, tests and their antidotes.
expert
A specialist or ____ in the scientific field of chemistry is called a chemist.
First in-man study

__________ is Phase-1 study in which a test product is administered to human
beings.
Formulation
__________ is a mixture of ingredients prepared in a certain way and used for a
specific purpose.
Pharmacodynamics
__________ is the study of physiological effects of drugs and the mechanisms of
their actions (what the drug does to the body)
Pharmacokinetics
__________ is the study of the bodily absorption, distribution, metabolism, and
excretion of drugs (what the body does to the drug)
pharmacologist
Chemists and ________(s) are also interested in how the medicine is administered, so
they often ask about its formulation.
Pharmacology
__________ is the study of drugs, how they work, and what they do in the body.
__________ can be divided into two separate areas: Pharmacodynamics and
Pharmacokinetics.
poison
Toxicology is the study of _____.
Toxicity
__________ is the degree to which a substance (a toxin or poison) can harm humans
or animals.
Toxicologist
__________ is an expert in the science of poisons.
Toxicology
__________ is the study of poisons.
Dosage
__________ is the amount and frequency of a medicinal drug that may be taken
safely.
Dosage form
__________ is the final form of the medicine, e.g. Tablet, powder, gel, spray, etc.
Dose
__________is the amount of substance given at one time.
Effervescent tablet
__________is an uncoated tablet containing substances that react in the presence of
water and give off carbon dioxide.
liquid
Some medications are available in _____ form, such drops or syrup.
Pill
__________ is a small, round piece of medicine to be swallowed without chewing.
Route of administration
__________ is the path by which a drug, fluid, poison, or other substance is taken
into the body.
Ailment
An __________ is an illness, especially one that is not very serious.
Allergic reaction
__________ is the body's exaggerated immune response to an internal or surface
agent.
anaemia
________is a medical condition in which there are too few red cells in your blood,
causing you to feel tired and look pale.
Asthma
__________ is a lung condition which causes difficulty in breathing.
Bronchitis
__________ is the inflammation of the bronchial tubes, characterized by coughing,
difficulty in breathing.
Chronic
A __________ illness or disability lasts for a very long time. Opposite to acute.
Diabetes
__________ refers to a group of diseases that affect how your body uses blood sugar
(glucose).
Diarrhoea
__________ is a condition in which faeces are discharged from the bowels frequently
and in a liquid form.
Eye drops
__________ are a kind of medicine that you put in your eyes one drop at a time.
favour
Which of the following dosage form(s) do the patients _____ (= prefer)?
Fever
If you have a __________ when you are ill, your body temperature is higher than
usual.
Hard gelatin capsule

__________ is a type of capsule that is usually used to contain medicine in the form
of dry powder or very small pellets.
Indigestion
If you have __________ , you have pains in your stomach and chest that are caused
by difficulties in digesting food.
Inhaled
__________ dosage forms are breathed in through mouth or nose and are often used
to treat respiratory diseases.
Inpatient
An __________ is someone who stays in a hospital while they receive their
treatment.
Insomnia
Someone who suffers from __________ finds it difficult to sleep.
Lotions
__________ are fluid preparations (aqueous) for external application without friction.
Lozenge
__________ is a solid preparation that is intended to dissolve or disintegrate slowly
in the mouth (e.g.. Sore throat)
Nasal spray
__________ is a substance dispensed as a fine spray from a container into the nostril.
Nausea
__________ is the condition of feeling sick and the feeling that you are going to
vomit.
Ointments
__________ are semi-solid, smooth greasy preparations for application to the skin for
healing.
Oral drops
__________ are liquid preparations for oral use that are intended to be administered
in small amount with the aid of a suitable measuring device.
Oral solution
__________ is a liquid in which another substance has been dissolved.
Patch
__________ is a medication on material or cloth placed on the skin.
Pneumonia
__________ is the inflammation of the lungs. The lungs become filled with liquid
which makes it difficult to breathe.
Septic
If a wound or a part of your body becomes __________ , it becomes infected.
Soft gelatin capsule

__________ is a type of capsule that is usually used to contain oils and for active
ingredients that are dissolved or suspended in oil.
Sublingual tablet
__________ is administered by placing it under the tongue.
aerosol
_______ is a container with a liquid that is administered in spray form.
breathe in
An Inhaler is a small device with medicine to _____ through the mouth.
device
An inhaler is an aerosol dispensing _____ which releases medication into the mouth
of the patient.
dissolve
Solution is a liquid in which another substance has been _____(d)
Gel
__________ is a drug delivery system consisting of a semi-solid, jelly-like substance.
Liniment
__________ is an oily liquid to rub on painful body parts to reduce pain.
melt
Suppository is a solid medicine which_____(s) slowly in the rectum or vagina.
rectum
Suppository is a solid medicine which melts slowly in the _______ or vagina.
Suppository
__________ is a solid medicine which melts slowly in the rectum or vagina.
Syrup
__________ is a sweet, liquid medicine taken with a spoon or cup.
Tablet
__________ is a hard, compressed medication in round, oval or square shape
Time-release delivery
__________ means a drug preparation that gradually releases an active substance
over a period of time.
Topical
__________dosage forms are applied to the skin surface.
apply
Patches are easy to _______, not too expensive, and can be placed right at the point
of pain.
Over-the-counter
__________ drug is a product which can be sold without the patient seeing a doctor.
abuse
One of criteria to obtain the status of OTC product in the US is that a medication
must have low potential for misuse and _____.
adequate
Pharmaceutical product labelling must provide ______ directions for sale and
effective use.
Behind-the-counter
__________medicine can be purchased without a prescription but only with the
personal involvement of a pharmacist.
directions
OTC Pharmaceutical products must have labelling that provides adequate _____ for
sale and effective use.
do harm
Medicine needs to be easily accessible. This is, of course, a question of public health.
On the other hand, these same products can _____ if used incorrectly. This danger
must be avoided.
incidence
must have low _______ of side effects.
involvement
In Canada, Behind-the-counter medicines are those that a patient can obtain without a
prescription, but only with the personal ______ of a pharmacist.
margin of safety
Medication must meet four criteria in order to obtain the status of a non-prescription
or OTC. It must have: a large ______, low incidence of side effects, low potential for
misue and abuse, and labelling that provides adequate directions for sale and effective
use.
misuse
Medication must meet four criteria in order to abtain the status of a non-prescription
or over-the counter (OTC) product. It must have: a large margin of safety, low
incidence of side effects, low potential for ______ and abuse, and - labelling that
provides adequate directions for sale and effective use.
policy
At present, the Food and Drug Administration is reviewing its current ______ on the
number of categories of medicines.
GAP
__________ stands for Good Auditing Practice.
GCP
__________ stands for Good Clinical Practice.
GDP
__________ stands for Good Documentation Practice
GLP
__________ stands for Good Laboratory Practice.
GMP
__________ stands for Good Manufacturing Practice.
GRP
__________ stands for Good Research Practice
GSP
__________ stands for Good Safety Practice
accuracy
All operational methods and procedures must also be inspected for ______.
adhere
Beyond the filed of manufacturing, good practice must be ______(ed) to in all
processes in a pharmaceutical company
Audit
An internal __________ involves inspection and validation of operational methods,
procedures, equipment to ensure functionality, accuracy and validity.
beyond
______ the field of manufacturing, good practice must be adhered to in all processes
in a pharmaceutical company. No process can be considered isolated from the others.
compliance
Endpoint testing is carried out at the end of every manufacturing process. This is to
ensure that all procedures have been performed in _________with industry and
company standards.
documentation
______ is important and necessary at every step of the processes, activities, and
operations involved in drug manufacturing.
Endpoint testing
At the end of every stage of a product's manufacturing process, __________ is done
to maintain quality standards.
ensure
Endpoint testing is carried out at the end of every manufacturing process to _____
that all procedures have been performed in compliance with industry and company
standards.
functional
Inspection and validation are required to prove that the manufacturing and testing
equipment is ______.
Good Manufacturing Practice

The quality assurance process in ______ (GMP) includes product quality control,
sampling, and testing.
Holistic approach
A __________ looks at all aspects of a pharmaceutical company together to make
sure that the entire process meets high industry standards.
in compliance with
ensure that all procedures have been performed ______ industry and company
standards.
inspection
______ and validation are required to prove that the manufacturing and testing
equipment is functional
interim testing
The reason for ________, or product sampling, is to check the quality of
pharmaceutical products
involved in
Documentation is important and necessary at every step of the processes, activities,
and operations ______ drug manufacturing.
maintain
Standard operating procedures (SOPs) are written and used by companies to make it
easier for them to follow GxP. These are a set of written instructions to
_____performance and results
manufacturing
The quality assurance process in good ______ practice (GMP) includes product
quality control, sampling, and testing.
operation
and ______(s) involved in drug manufacturing.
operational
All _______ procedures and methods must also be inspected for accuracy.
performance
easier for them to follow GxP These are a set of written instructions to maintain
______ and results
Procedure
ensure that all _______(s) have been performed in compliance with industry and
company standards.
process
The quality assurance ______ in good manufacturing practice (GMP) includes
product quality control, sampling, and testing.
Product sampling
The reason for interim testing, or __________, is to check the quality of
pharmaceutical products.
proper
______ documentation not only enables traceability, but also allows a complete
product recall from the market, if necessary.
Standard operating procedures (SOPs)
_________ are a set of written instructions to maintain performance and results. They
are the basis of good QA and QC system.
to enable
Proper documentation not only _____(s) traceability, but also allows a complete
product recall from the market.
Validation
Manufacturing processes and procedures must go through periodic __________ to
guarantee that they are still of an acceptable standard.
adverse drug reaction

Even a product that has been marketed for years might have to be taken off the
market if serious _________(s) occur.
Contaminated
__________ drugs are no longer pure and acceptable for sale or public use and,
therefore, must be returned to the manufacturer, or destroyed.
manufacturer
Contaminated products are no longer pure and acceptable for sale or public use and,
therefore, must be returned to the ______ or destroyed.
Product recall
market in a __________ if serious adverse reactions occur.
pure
Contaminated products are no longer _______ and acceptable for sale or public use
and, therefore, must be returned to the manufacturer, or destroyed.
Quality assurance
__________ involves all manufacturing processes in GMP which make sure the
goods produced are kept at high standards.
Quality control
__________ involves interim and product sampling procedures, which are carried out
to check product quality.
Traceability
The documentation required for all research processes and development steps ensures
the __________ of a drug.
advise
This memo is to_____ you that your department has been scheduled for a periodic
audit of the laboratory safety systems and procedures.
annual
A(n)_____ audit of safety procedures in all laboratories is carried out yearly.
assure
The goal of an internal audit is to identify any areas requiring corrective or preventive
actions. It is done to ______ compliance with industry standards, especially for safety
procedures.
auditor
A/An __________ inspects and verifies the safety procedures in the lab.
confirm
Please ______ receipt of this memo and send us a copy of all your correspondence
with regard to this scheduled audit.
internal
An _____ audit involes inspection and validation of operational methods, procedures,
equipment to ensure functionality, accruacy and validity
receipt
Please confirm _____ of this memo and send us a copy of all your correspondence
action
Corrective _____ / Preventive ______ ( CAPA ) is a part of the overall Quality
Management System ( QMS) required for GMP .
CAPA
__________ stands for Corrective Action/Preventive Action. It is a part of the overall
Quality Management System (QMS) required for GMP
Corrective action
__________ prevents recurrence of errors
deviation
Corrective Action/Preventive Action (CAPA) focuses on the systematic investigation
of non-conformance events (errors or _______(s)), to prevent their occurrence (for
preventive action) or recurrence (for corrective action).
focus
Corrective Action/Preventive Action (CAPA) is a part of the overall Quality
Management System (QMS) required for GMP. It ____(es) on the systematic
investigation of non-conformance events (errors or deviations), to prevent their
occurrence (for preventive action) or recurrence (for corrective action).
occurrence
Preventive action prevents ______ of errors.
Preventive action
__________ prevents occurrence of errors
Quality Management System

__________ (QMS) is a formalized system that documents processes, procedures,
and responsibilities for achieving quality policies and objectives.
recurrence
CAPA focuses on the systematic investigation of non-conformance events (errors or
deviations), to prevent their occurrence (for preventive action) or_______ (for
corrective action).
advance notice
_______ of this meeting was very short.
categorize
Any observation or finding noted by the auditors is _______(d) as either major,
minor, or critical.
Checklist
To ensure that laboratory workers are asked certain questions about safety
procedures, auditors use a __________.
double-check
We should tell the lab staff to _____ that all the labs are spotlessly clean and that all
lab devices and equipment are where they should be - at every single workstation.
Finding
Any observation or _______ noted by the auditors is categorized as either major,
minor, or critical.
non-compliance
If any __________ is observed during the audit, the department will be informed so
they can take corrective action.
observe
Auditors generally watch or _______safety procedures in the lab.
Safety procedures
__________ make sure that the health and well-being of laboratory workers are
guaranteed.
up-to-date
Scientists often read journals and go to international conferences, because they need
to stay _________ in their scientific fields.
Overshoes
__________ are shoe covers used to reduce foot borne contamination and help
maintain a sterile environment.
pain relief
Aspirin mainly used for ______ and fever.
Eye bath
___________ is a/an apparatus to wash the eyes after exposure to chemical
contamination.
Fire blanket
A/an __________ is a safety device consists of a sheet of a fire retardant material
which is placed over a fire in order to extinguish it.
follow-up
Although there were no serious instances of non-compliance, a number of incidents
of undesirable conditions and practices were observed. These need to be corrected
before the _______ review in 30 days
Gas mask
A/an __________ is a device that you wear over your face in order to protect yourself
from poisonous gases.
improper
_______ disposal of toxic waste material was recorded. (= incorrect/ wrong)
cage
It is absolutely essential to move lab mice outdoors in closed ____(s) .
covered
Lab animals must be transported in _____ cages.
dispose
I suggest you _____ of toxic waste in the bins provided for this purpose.
accordance with
All laboratory work must be documented in ________ GLP.
biological agent
Small _______ spills must be covered with a paper towel and treated with bleach .
bio-safety cabinet
All work with virus- infected animals must be performed in the _______.
bleach
Small biological agent spills must be covered with a paper towel and treated with
________ .
clarify
To ______ something means to make it easier to understand, usually by explaining it
in more detail.
disinfect
You need to ______ all equipment following any experiments with laboratory
animals.
disinfectant
______ must be used on all equipment following any experiments with laboratory
animals.
equipment
Proper protective clothing and safety ______ must be worn at all times
experiment
Disinfectant must be used on all equipment following an _______ with laboratory
animals.
goggles
Protective glasses/_____ must be worn at all times in the laboratory.
hazardous
Toxic or ______ materials must be disposed of properly.
protective clothing
Proper ______ and safety equipment must be worn at all times.
bacterial
Validation of cleaning processes is essential in this industry, because chemical or
_______ contamination of drug products can potentially lead to severe public health
risks.
cause
According to reports, it seems that an unanticipated reaction between the drug's
active ingredient and the chemicals used as part of the cleaning processes at the site
was the ______ of the contamination.
claim
A few years ago, a well-known European pharmaceutical company was forced to
recall one of its drugs due to _____s of product contamination.
complaint
A product recall took place following reports from patients that their medication had
a strange odour. Several patients from a number of different countries made the
_______ within a short period of time.
container
Special ______(s) are provided for the disposal of toxic waste materials.
contamination
recall one of its drugs due to claims of product _____.
danger
The company claims that a cleaning error was the reason for the entire incident. This
clearly underlines the ______ of underestimating the importance of the cleaning
process in pharmaceutical manufacturing.
disposal
Special containers are provided for the _______ of toxic waste materials.
due to
A well-known European pharmaceutical company was forced to recall one of its
drugs ________ claims of product contamination.
force
A well-known European pharmaceutical company was ____(ed) to recall one of its
drugs due to claims of product contamination.
Genotoxic substance
__________ is a chemical that damages cellular DNA, resulting in mutations or
cancer.
global
recall one of its drugs due to claims of product contamination. The drug manufacturer
was unable to say just how many patients were taking this drug at the time. However,
it estimated the _____figure at over 40,000 people.
Odour
An __________ is a distinctive unpleasant smell.
Creams
__________ are semi-solid emulsion, that is mixtures of oil and water.
act on
A drug that is intended to______ the sinuses may be formulated as a time-release
capsule, or as a nasal spray.
administer
In the preclinical stage of drug development, an investigational drug must be tested
extensively in the laboratory. This is to ensure it will be safe to _____to humans.
clinical
The results of all testing must be provided to the FDA in the United States and/or
other appropriate regulatory agencies in other countries in order to obtain permission
to begin ______ testing in humans.
CMC
_______ stands for Chemistry, Manufacturing and Controls. It is a part of new
pharmaceutical product application to the US Food and Drug Administration.
in vitro
__________ means "in cells in a test tube"
in vivo
__________ means "in living organisms"
investigational drug
In the preclinical stage of drug development, a(n) ______ must be tested extensively
in the laboratory. This is to ensure it will be safe to administer to humans.
obtain
other appropriate regulatory agencies in other countries in order to ____ permission
to begin clinical testing in humans.
organism
During the preclinical developmentof a drug,laboratory tests document the effect of
the investigational drug in living ______,and in cells in a test tube (in vitro).
potency
Regulatory agencies require testing that documents the characteristics -chemical
composition,purity quality,and _______ -of thedrug's active ingredient,and of the
formulated drug.
potential
Toxicology ís the study of the _______risks to the body.
commence
Regulatory agencies have to give permission to ______ with the clinical testing in
humans, which is also done at our company.
intention
First of all, it is the _______ of the company to complete the preclinical trials by the
end of the year.
appropriate
Extensive documentation must be provided to the _______ regulatory authorities.
authorization
The active ingredient can be tested in humans only after these tests have been
successfully completed and _______ has been given.
Biology lab technician

A __________ works with living organisms.
Chemistry lab technician

A __________ assists chemists and chemical engineers using chemicals and related
products
concentration
Low-dose/mid-dose/high-dose groups are three groups of animals which receive
different _______(s) of the medication understudy.
Control group
A _______ in preclinical studies is a group of test animals that is not exposed to the
medication under study. In an experiment, this group is treated just like the other
animals, but does not receive the active ingredient. This group is then compared with
the treated animals in order to validate the results of the test.
impromptu
Miki has been invited to join an ______ lab meeting about drug substance MPP
010098, which is being tested in dogs. ( = without planning or organizing it in
advance.)
Preclinical studies
____________ refer to the testing of an investigational drug, a procedure, or another
medical treatment in the laboratory to ensure it will be safe to administer to humans.
(also called preclinical development)
abnormality
__________(s) regarding food consumption were observed shortly after
administration in the high- dose group.
appearance
In addition, the overall ______ and behaviour of each animal was assessed twice a
day
behaviour
The general health and ______ of the dogs were checked twice a day.
consumption
The general health of the dogs was regularly checked. On Day 2, abnormalities
regarding food ______ were observed shortly after administration in the high-
dosegroup.
observation
The dogs started retching and vomiting and were separated to allow closer ______.
Absorption
Drug __________ is the movement of a drug from its site of administration into the
blood.
approval
Phase III is the final phase before getting marketing ________.
benefit-risk
After gaining evidence that the drug is effective, these controlled and uncontrolled
trials are carried out to obtain additional information to evaluate the overall ______
relationship of the drug.
disorder
Phase II is the first phase in which patients with the target disease or ______ take
part.
Distribution
Drug __________ is the movement of drugs throughout the body after absorption.
effectiveness
Phase II Trials are controlled studies conducted to evaluate the ______ of the drug in
a particular indication and to determine possible side effects and risks.
evaluate
Phase I Trials: These are studies which are performed to ____ the safety of drugs in
healthy people and to determine the pharmacological properties of drugs.
Excretion
Drug __________ is the removal of a drug or its metabolites from the body.
exposure
Phase III Trials: A large group of patients is studied and closely monitored by
physicians for efficacy and any adverse events after long-term ____ to the drug.
gather
Phase IV Trials: They are carried out in order to ____ further information about the
drug's safety, efficacy, and optimal use.
healthy
Phase I Trials: These are studies which are performed to evaluate the safety of drugs
in ______ people, and to determine the pharmacological properties of drugs.
indication
Phase II Trials: These are controlled studies conducted to evaluate the effectiveness
of the drug in a particular _______ and to determine possible side effects and risks
marketing approval
Phase III is the final phase before getting ______.
Metabolism
Drug __________ describes the chemical reactions catalysed by enzymes that change
drugs into compounds which are easier to eliminate.
Metabolites.
The products of drug metabolism are called _____.
Phase I
__________ is performed to evaluate the safety of drugs in healthy people, and to
determine the pharmacological properties of drugs
Phase I
In __________ the drug reacts in the body, toxicity, metabolism, absorption, and
excretion are observed and documented.
Phase II
__________ is the first phase in which patients with the target disease or disorder
take part.
Phase II
In phase _________, testings are done to determine the safety and efficacy of the
drug in treating the condition and establishes the minimum and maximum effective
dose.
Phase III
__________ is performed after there is preliminary evidence that the drug is effective
to obtain additional information to evaluate the overall benefit-risk relationship of the
drug.
Phase III
__________ is the final phase before getting marketing approval.
Phase III
In __________, a large group of patients is studied and closely monitored by
physicians for efficacy and any adverse events after long-term exposure to the drug.
Phase IV
__________ is the post-marketing study after getting approval for general sale.
Phase IV
In phase__________ , further information regarding drug's safety, efficacy, and the
ideal(optimal) use of the drug is collected.
abnormal
An adverse event is any _____ medical occurrence in a patient or clinical trial subject
after a medicinal product has been administered .
Adverse event
An __________ is any abnormal medical occurrence in a patient or clinical trial
subject after a medicinal product has been administered. It does not necessarily have
a causal relationship with the medicinal product.
causal relationship
An adverse event is any abnormal medical occurrence in a patient or clinical trial
a ______ with the medicinal product.
evidence
Phase II is performed after there is preliminary _____ that the drug is effective.
medicinal
subject after a ________ product has been administered.
placebo
Test subjects in the treatment group receive the medication under study, whereas the
control group receives either a standard medication or a _____.
preliminary
Phase II clinical trial is performed after there is _____evidence that the drug is
effective.
response
Adverse reaction refers to all abnormal and unintended _____to an investigational
medicinal product related to any dose administered.
Adverse reaction
_______ refers to all abnormal and unintended responses to an investigational
affect
The active ingredient currently being tested seems to ______the kidneys.
Briefly
__________ means 'for a short time' . e.g. The trial director spoke __________ to his
staff about the current status of the trial.
Disease
A __________ is an abnormal condition that affects the body of an organism, often
caused by pathogens. e.g. There is a history of lung __________ in the family.
Effect
__________ is the result of a change. e.g. I felt the __________ of the new ointment
right away.
Illness
__________ is used to describe a person who is in a poor state of health. e.g. He
missed five days of work because of _________.
Sensible
__________ means practical and reasonable. e.g. It was a __________ decision to
cancel the trial.
Sensitive
__________ means quick to detect or respond to slight changes, or influences. e.g.
Dogs are more __________ to drugs than mini-pigs.
Shortly
__________ means 'soon'. e.g. The adverse event occurred shortly after the injection.
authority
The parents of a 21-year-old woman challenged the FDA.They took the _______ to
court after their daughter had died of cancer.
cancer
______ is a serious disease in which cells in a person's body increase rapidly in an
uncontrolled way, producing abnormal growths.
court
The parents took the authority to _____ after their daughter had died of cancer.
efficacy
The safety and ______ of a drug can only be determined by conducting rigorous
clinical trials, according to the FDA.
experimental drug
Clinical trials are mainly aimed at answering scientific questions. In general, their
goal is to gather statistics to determine whether an ______ is safe and effective.
fall victim to
Many terminally ill people _____ the 'therapeutic misconception that the objective of
trials is to cure them.
legal right
Do terminally ill patients have the ______ to try to prolong their lives by taking
experimental drugs?
misconception
Many terminally ill people fall victim to the therapeutic _______ that the objective of
randomly
Subjects in a trial must be willing to be _______ assigned to either the group which
receives the unapproved medication or the one which gets a placebo
rigorous
The safety and efficacy of a drug can only be determined by conducting _____
dossier
Regulatory Affairs department is responsible for compiling the ________ for
submission to drug regulatory authorities.
Drug Safety
__________ department is responsible for monitoring and evaluating suspected side
effects, reporting an adverse drug reaction to health authorities, and responding to a
physician's report.
healthcare professionals
PHARMACOVIGILANCE - Government agencies, pharmaceutical companies, and
__________ work together to monitor and evaluate suspected side effects of
medicines to improve the safety of drugs in use.
monitor
Government agencies, pharmaceutical companies ,and healthcare professionals work
together to _____and evaluate suspected side effects of medicines to improve the
safety of drugs in use
Pharmacovigilance
_________ Government agencies, pharmaceutical companies, and healthcare
professionals work together to monitor and evaluate suspected side effects of
Regulatory Affairs
__________ department is responsible for compiling dossiers for submission to
authorities, submitting documents needed to obtain marketing approval for a drug,
and writing the drug information for the patient.
accompanied
At the hospital, the patient showed evidence of hyperactivity , _______ by confusion
and agitation.
Adverse event
__________ is an unwanted medical occurrence which a patient experiences during
treatment. This may or may not be a side effect of a drug.
agitation
At the hospital, the patient showed evidence of hyperactivity , accompanied by
confusion and _______.
blood pressure
hypertension means high _______.
confusion
At the hospital, the patient showed evidence of hyperactivity, accompanied by
______ and agitation.
consciousness
Ms Gallois, the well-known opera singer, lost _______ 30 minutes before she had
planned to go on stage. ( = the condition of being awake and able to understand what
is happening around you)
contraceptive
______ is a drug or method used to prevent a woman from becoming pregnant when
she has sex.
discharge
After 24 hours, all symptoms except for a mild skin irritation had subsided and the
patient was_____(ed) from hospital.
experience
Adverse event is an unwanted medical occurrence which a patient _____(s) during
history
The patient has a ______ of hypertension, mild heart palpitations, high adrenalin
levels,and often suffers from insomnia.
hospitalization
Serious adverse event (SAE) - an adverse event that threatens life, requires or
prolongs _______, or results in death.
Serious adverse event

__________ (SAE) is an adverse event that threatens life, requires or prolongs
hospitalization, or results in death.
Side effect
__________ is any unintended reaction caused by a drug or medical treatment. This
term is used by the general public, but is often avoided by medical authorities.
Vital signs
The patient's normal __________ (pulse, blood pressure, respiratory rate and
temperature) are established in the pre-operative period and variations 10% above or
below the pre-operative measurement should be reported immediately.
attending physician
After examining the patient, the _______ reduced the dosage to 10 mg per day .
correlation
A _______ between Mensamint and the symptoms cannot be ruled out.
dizzy
If you feel _______, you feel that you are losing your balance and are about to fall.
faint
If you ______, you lose consciousness for a short time, especially because you are
hungry, or because of pain, heat, or shock.
Hypertension
__________ is when blood pressure is higher than normal (e.g. A blood pressure of
140/90)
Hypotension
__________ is when blood pressure is lower than normal (e.g. A blood pressure of
65/70).
Inflammation
Symptoms of __________ include: red, warm, and swollen.
Irritation
__________ means general discomfort, bad feeling.
Itching
__________ is when you feel like you want to scratch.
Rash
Someone has a ___________, that person has a lot of spots on the skin.
sedative
____ is a drug used to make someone calm or go to sleep.
case report
Pharmaceutical companies use details from doctors' reports to inform the authorities
in a ______.
Allergic
Do not take Mensamint TM if you are _______ to peanut.
allergy
The patient has an _____ to peanuts.
concomitantly
The patient was ______ taking the following medication:Mimifem oral contraceptive
pill and Mensamint.
emotional
As to her _____state after hospital admission,the patient showed side effects of
hyperactivity, accompanied by confusion and a feeling of agitation.
hospital admission
As to her emotional state after ________, the patient showed evidence of
EMEA
The ___________ is a European Union agency for the evaluation of medicinal
products.
FDA
The __________ is the Food and Drug Administration (US) It is responsible for
ensuring that food, drugs, and certain other products and processes are safe for
consumers.
MHRA
The ________ is an executive agency of the Department of Health in the United
Kingdom which is responsible for ensuring that medicines and medical devices work
and are acceptably safe.
QPPV
__________ stands for Qualified Person Responsible for Pharmacovigilance.
disprove
The evidence is inconclusive.The facts neither prove nor ____ this.
inconclusive
Although the evidence is _______, a reaction to Mensamint cannot be completely
ruled out.
compile
In order to get approval to sell a new drug, a company has to _____ detailed
documentation with all the information required by the drug authorities
confused
When you talk about PILs, say each letter. If not, it might be _____with 'pills'
leaflet
Important information for any person taking a drug can be found in the 'PIL'or patient
information _____.
marketing authorization
____ is an official document issued by the drug regulatory authority for the purpose
of marketing or free distribution of a product after evaluation for safety, efficacy and
quality.
patient information leaflet

Important information for any person taking a drug can be found in the _________.
PILs'
_________ means patient information leaflets.
alarm
We do need to let patients know of any possible side effects. But, it is not necessary
to _____them unnecessarily.
brief
I just wanted to give you a _____ update on the self-inspection conducted last week
by QA
conduct
Iris Berger from HR will place job ads in several major pharmaceutical journals to
look for two new clinical research associates to ______ the trials in the test centres in
France.
differentiate
When describing possible side effects for products in the pipeline, we will need to
______more clearly between frequent and rare risks.
frequent
differentiate more clearly between _____ and rare risks
patient compliance
Better styling in the PIL could increase______.
Active substance
The __________ of Mensamint TM is mensagitatum. Other ingredients are
peppermint, oil, sugar, talcum, and a preservative.
consult
If you have a history of heart trouble, ______ your doctor before taking this
medicine.
frequency
The 'Possible side effects' section of a Patient Information leaflet categorizes known
side effects according to their ______.
high-profile
A ______ person or a _______ event attracts a lot of attention or publicity. (=
famous)
jargon
______ means the specialized language used by people in the same work/ profession
or industry.
preservative
Mensamint is a lozenge to support increased concentration. The active substance is
mensagitatum. Other ingredients are peppermint, oil, sugar, talcum, and ______.
probability
Our patients shouldn't be so alarmed that they are afraid to actually put the pills in
their mouth and swallow them. The PIL just needs to reflect the _______ of side
effects.
antibiotic
Do not take Penicillin if you are allergic to any ______(s).
dizziness
Mensamint may cause _______.(a sensation of spinning around and losing one's
balance)
Out of reach
Keep _________ of children.
reach
Keep out of ______ of children.
abdominal
_____ pain is the pain in your stomach or intestines.
active pharmaceutical ingredient
You investigate the adverse event by looking for similar side effects in the
documentation and report it to the authorities. Still, nothing even vaguely similar can
be found for either the ______(API) or any of the excipients.
advent
With the _______ of online pharmacies, open borders and uncontrolled chemical
laboratories all over the world, the number of counterfeit drugs is on the rise, not only
in developing but also in industrialized countries.
aftertaste
It has the same packaging, same colour coating, same bitter _______, but not the
same ingredients inside the pill. Is this a fake drug?
API
_________ stands for (active pharmaceutical ingredient)
authenticity
In Europe, steps have been taken to use holograms to prove a pharmacopeias ______.
coating
Fake drug may have the same packaging, same colour _______, same bitter
aftertaste, but not the same ingredients inside the pill.
common
_____ side effects of CAREFREEDO are: nausea, vomiting, abdominal pain (pain in
your stomach or intestines)
Counterfeit
_________ drugs may contain: a worthless placebo; a lower concentration of the
same active ingredient; a similar, but different substance; a totally different,
potentially dangerous substance.
despite
_____ more international co-operation in the fight to stop counterfeit drugs, some
countries have unfortunately not taken action.
elevated
In rare cases, CAREFREEDO may cause the following side effects: ______ blood
pressure, dizziness, allergic reactions...
Excipient
____ is an inactive substance that serves as the vehicle or medium for a drug or other
active substance.
fake
____ drugs may contain: a worthless placebo; a lower concentration of the same
active ingredient; a similar, but different substance; a totally different, potentially
dangerous substance.
fatal
A _____ accident or illness causes someone's death.
hay fever
_____ is a seasonal allergy to pollens.
industrialized
The number of counterfeit drugs is on the rise, not only in developing but also in
______ country
intestines
Abdominal pain is the pain in your stomach or ______.
Pharmacopeia
____________ is an official publication containing a list of medicinal drugs with
their effects and directions for their use.
pollen
____ is a fine powder produced by flowers, which is carried by the wind or by insects
to other flowers of the same type, making them produce seeds.
enterprise
Nowadays, RRB is a research-driven,innovative pharmaceutical ___ that develops
new drugs, produces them, prepares them for sale, and markets them worldwide.
premises
______ is a place where company has its offices and/ or factories.
effervescent
_______ tablets are uncoated tablets containing substances that react in the presence
of water and give off carbon dioxide.
lab coat
__________ protects the scientist and the scientist's clothes from hazardous or hot
chemicals
rubber gloves
__________ protect hands from chemical compounds
Safety goggles
__________ are used to protect your eyes are you work in the lab such as chemical
splashes/spills.
corrosive
Please mind the _____ substances, which could cause severe burns.
hard hat
A _____ must be worn at all times in this area to protect your head.
polite
If you give instructions in a very direct way, it may not sound _____.
Safety
__________ is the freedom from danger or harm.
Security
__________is the protection from threats, such as attacks or crime.
dispenser
_____ is a machine/ mechanism which releases its contents in defined amounts.
drum
A __________ holds the pressed tablets until it is time to coat them.
Fluid bed dryer

The granules are air-dried in the __________.
coat
A drum holds the pressed tablets until it is time to ______ them
Excess powder remover

In the _________, As the tablets go up a spiral, they are shaken, and the excess
powder is vacuumed off. The pressed tablets are put into a drum and stored until it is
time to coat them.
Granulator
In the _________, the ingredients are mixed to create a wet mixture.
granule
The dried ____(s) are stamped into a mould to form tablets.
Hoist
Dry ingredients are weighed and transported to the granulator by the __________.
moisture
The ______ is removed by the hot air in the fluid bed dryer.
mould
The dried granules are stamped into a _____ to form tablets.
shaker
A __________ loosens the excess powder.
Sieve
The wet granules are pressed through a _________ on their way to the fluid bed
dryer.
Tablet press
The dried granules are stamped into a mould to form tablets in the __________.
vacuum
A __________ system sucks up the excess powder.
calibrate
Lab equipment should always be clean or sterile and ______(d) before using it.
comply with
Pharmaceutical companies have to ______ GMP guidelines
content weight
During the manufacturing process, technicians also check the samples for content
uniformity, ______, and so on.
guidelines
Pharmaceutical companies have to comply with GMP ____.
mix-up
Well, we have to make sure that there are no ______(s) (mistake) of materials
throughout the whole manufacturing process.
optimize
GMP covers how to design and construct buildings so that the flow of materials is
______(ed), and so that they can be cleaned easily.
reliable
In order to receive valid and _____ results, all devices and methods have to undergo a
validation process.
uniformity
_______, content weight, and so on.
humidity
_________ is the amount of water vapor in the air
blister pack
A(n) __________ is a type of single-use plastic container, and is used for
pharmaceutical products as well as for other consumer goods. The product is placed
in the formed cavity and sealed by lidding foil. The product is removed by pushing it
through the foil.
bottle
Which primary packaging is the most suitable for nose drops?
cap
A jar is a multi-use glass container with a twist-on lid. It can hold pharmaceuticals, or
any kind of fluids or solids. It can be opened and closed several times until the
contents are used up. Sometimes a desiccant is integrated into the ______ so that the
contents remain dry.
content
______(s) are used up. Sometimes a desiccant is integrated into the cap so that the
_______(s) remain dry.
desiccant
contents are used up. Sometimes a _____ is integrated into the cap so that the
disposable
A sachet is a small ______ bag containing an individual dose of the medicine. It often
has a lengthwise perforation which can be torn open.
foil
A blister pack is a type of single-use plastic container, and is used for pharmaceutical
products as well as for other consumer goods. The product is placed in the formed
cavity and sealed by lidding ______. The product is removed by pushing it through
the ____.
individual
A sachet is a small disposable bag containing a(n) ______ dose of the medicine. It
often has a lengthwise perforation which can be torn open.
Inhaler
A(n) __________ is an aerosol dispensing device which releases medication into the
mouth of the patient. The medication is breathed deeply into the lungs, or stays in the
mouth or throat.
jar
A(n) __________ is a multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be opened and closed several
times until the contents are used up. Sometimes a desiccant is integrated into the cap
so that the contents remain dry.
Primary packaging
__________ is the material which is in direct contact with the product.
sachet
A(n) __________ is a small disposable bag containing an individual dose of the
medicine. It often has a lengthwise perforation which can be torn open.
Secondary packaging
__________ is any packaging material that is not in direct contact With the product.
sticky label
A(n) __________ is a piece of paper attached with adhesive to the primary packaging
to identify it and give details concerning its ownership, nature, and/or use.
syringe
A(n) __________ is a needle attached to a plastic tube used for putting medicine into
the body or removing blood.
tube
Which primary packaging is the most suitable for ointments?
accessible
A lot of research is done to make packaging childproof,i.e. a child cannot open it
alone. However, at the same time, the elderly must have easy access to their
medication,i.e.it needs to be elderly-_______.
align
Slide container system is a container with three buttons that must be ____(ed) in
order to slide off the lid .
catch
A tube that can only be released by an adult-length finger by pushing an internal
______.
childproof
__________ means a child cannot open it alone.
closure
In a "push-screw" container system, a _______ must be pushed down before it can be
unscrewed.
elderly-accessible
The elderly must have easy access to their medication,i.e.it needs to be __________.
peel-push system (Container system)

A first layer must be peeled off a blister before the drug can be pushed through the
second layer.
poke (Container system)

catch.
push-screw (Container system)

A closure must be pushed down before it can be unscrewed.
slide (Container system)

A container with three buttons that must be aligned in order to slide off the lid.
squeeze-screw (Container system)

A closure must be squeezed between two fingers before it can be unscrewed.
anticipate
The boy's death highlighted a problem that no one had _______(d) up to that time .
community service
A mother was sentenced to several years' ________ for leaving a used medical patch
in a place where her young son could have access to it.
convict
If someone is ______(d) of a crime, they are found guilty of that crime in a law court.
demand
Because of her son's death, the young mother _____(ed) that safe-disposal boxes be
included in the packages of medicated patches.
discard
Safe-disposal boxes should be included in the packages of medicated patches. These
boxes should have a small slit at the top to _____ used patches and it should be
impossible to open them.
negligence
A few years ago, a mother was convicted of _______ leading to her son's death. ( =
Failure to take proper care over something/someone)
overdose
A few years ago, a mother was convicted of negligence leading to her son's death. It
was claimed that he had died from a pain medication _____.
pain relieving
A four year old boy was found dead after he had stuck a highly potent, ______ patch
to his leg
Thuật ngữ trong học phần này (269)
Thứ tự gốc
WNL
If a function is ______ (Within Normal Limits), it is operating in a normal range.
XR
An X-ray is a visual image of all or part of the body acquired with special equipment
using electromagnetic radiation to see bones and other internal aspects of the body.
BP
(Blood Pressure) is the force exerted by circulating blood on the walls of blood
vessels. Lt is a vital sign that medical professionals use to determine whether body
systems are operating as they should.
c/o
Dx
(Diagnosis) is the positive identification of a patient's disease or ailment.
HR
HTN
o/e
Rx
SOB
than usual.
T

drop (gtt)
gram (g)
gtt
microgram (mcg)
major component.
milligram (mg)
milliliter (ml)
centimeter.
ounce (oz)
three teaspoons.
teaspoonful (tsp)
five milliliters.
administer
dosage
I.V.
IM
P.0.
P.R.
SQ
syringe.
SL
topical
Medicine is applied to a certain part of the surface of the body.
complaint
onset
cold
wheeze
ac
BID
pc
PRN
qh
qhs
QID
QOD
stat
TID
allergy
current
data

history of
repeatedly.

medical details.
procedure
social history
and marital status.
cough
irritation.
fever
flu
headache
muscle ache
runny
symptom
throb
affect
auscultation
body language
evaluate
inspection
observation
palpation
percussion
pulse
vital signs
albumin
biopsy
blood pressure


time.
creatinine

pathology report
examined.
renal
urinalysis
CT scan
electrocardiogram
period of time.
endoscope
body cavity.
feed
pictures,
gel
probe.
medical imaging

radiography
ultrasound
x-ray
human body
advertisement
Clinical Affairs
compound
the patients.
drug authority
drug documentation
effective
Ingredient
market
Marketing and Sales

Production
promotion

Regulatory Affairs

Analgesic
apply for
Colleague
conclusion
encouraging
launch
Liaise
marketing claim
memo
on board
______
pipeline
Preclinical data
trials.
Prescription
from the doctor.
determine
Feasibility study
investigation
powder
practicality
profitability

cross-functional
deadline
Medical writer
medication
meet requirements
oily
Ointment
production line
Project manager
launch a drug.
Qualified person
Health regulations
adverse
develop
health authority
operate
pharmaceutical
assigned to
organization.
conceptual design
degree
deliverables
expertise
licence
methodology
B.S.
BSc
MS
MSc
cost estimate
the month.
finalize
milestone
accurate
analytical testing

anti-depressant
cheerful
considerably
authorities allow.
consultant
cough
cough syrup
Cross-cultural
cure
interesting.
custom
imperfection
packaging
remedy
Self-medicate
Subsidiary
beneficial effect
carry forward
Clinical trial
Development
discovery
Research
breakthrough
chew
New chemical entity

Obtainable
prescription only)
occasionally
occur
palpitations
Bioavailability
Chewable tablet
drug administration
harmful
antidote
Chemist
composition
expert
First in-man study

beings.
Formulation
specific purpose.
Pharmacodynamics
Pharmacokinetics
pharmacologist
Pharmacology
Pharmacokinetics.
poison
Toxicity
or animals.
Toxicologist
Toxicology
Dosage
safely.
Dosage form
Dose
Effervescent tablet
liquid
Pill
into the body.
Ailment
Allergic reaction
agent.
anaemia
Asthma
Bronchitis
Chronic
Diabetes
(glucose).
Diarrhoea
Eye drops
favour
Fever
usual.

Indigestion
Inhaled
Inpatient
treatment.
Insomnia
Lotions
Lozenge
Nasal spray
Nausea
vomit.
Ointments
healing.
Oral drops
Oral solution
Patch
Pneumonia
Septic

Sublingual tablet
aerosol
breathe in
device
of the patient.
dissolve
Gel
Liniment
melt
rectum
Suppository
Syrup
Tablet
Topical
apply
of pain.
Over-the-counter
abuse
adequate
effective use.
Behind-the-counter
directions
do harm
must be avoided.
incidence
involvement
margin of safety
use.
misuse
policy
AP
GCP
GDP
GLP
GMP
GRP
GSP
accuracy
adhere
Audit
beyond
compliance
company standards.
documentation
Endpoint testing
ensure
standards.
functional

Holistic approach
in compliance with
standards.
inspection
interim testing
involved in
maintain
manufacturing
operation
operational
performance
______ and results
Procedure
company standards.
process
Product sampling
proper

to enable
Validation
Contaminated
manufacturer
Product recall
pure
Quality assurance
Quality control
Traceability
advise
annual
assure
procedures.
auditor
confirm
internal
receipt
action
CAPA
Corrective action
deviation
focus
occurrence
Preventive action

recurrence
corrective action).
advance notice
categorize
minor, or critical.
Checklist
double-check
Finding
minor, or critical.
non-compliance
observe
Safety procedures
guaranteed.
up-to-date
Overshoes
pain relief
Eye bath
contamination.
Fire blanket
follow-up
Gas mask
improper
cage
covered
dispose
accordance with
biological agent
bio-safety cabinet
bleach
________ .
clarify
in more detail.
disinfect
animals.
disinfectant
animals.
equipment
experiment
animals.
goggles
hazardous
protective clothing
bacterial
risks.
cause
claim
complaint
container
contamination
danger
disposal
due to
force
Genotoxic substance
cancer.
global
Odour
Creams
act on
administer
clinical
CMC
in vitro
in vivo
obtain
organism
potency
formulated drug.
potential
commence
intention
end of the year.
appropriate
authorization


products
concentration
Control group
impromptu
advance.)
Preclinical studies
abnormality
appearance
day
behaviour
consumption
dosegroup.
observation
Absorption
blood.
approval
benefit-risk
disorder
part.
Distribution
effectiveness
evaluate
Excretion
exposure
gather
healthy
indication
marketing approval
Metabolism
Metabolites.
Phase I
Phase I
Phase II
take part.
Phase II
dose.
Phase III
drug.
Phase III
Phase III
Phase IV
Phase IV
abnormal
Adverse event
causal relationship
evidence
medicinal
placebo
preliminary
effective.
response
Adverse reaction
affect
Briefly
Disease
Effect
right away.
Illness
Sensible
cancel the trial.
Sensitive
Shortly
authority
cancer
court
efficacy
experimental drug
fall victim to
legal right
experimental drugs?
misconception
randomly
rigorous
dossier
Drug Safety
physician's report.
monitor
Pharmacovigilance
Regulatory Affairs
accompanied
and agitation.
Adverse event
agitation
blood pressure
confusion
consciousness
contraceptive
she has sex.
discharge
experience
history
hospitalization

Side effect
Vital signs
attending physician
correlation
dizzy
faint
Hypertension
140/90)
Hypotension
65/70).
Inflammation
Irritation
Itching
Rash
sedative
case report
in a ______.
Allergic
allergy
concomitantly
pill and Mensamint.
emotional
hospital admission
EMEA
products.
FDA
consumers.
MHRA
QPPV
disprove
inconclusive
ruled out.
compile
confused
leaflet
information _____.
quality.

PILs'
alarm
brief
by QA
conduct
France.
differentiate
frequent
patient compliance
Active substance
consult
medicine.
frequency
high-profile
famous)
jargon
or industry.
preservative
probability
effects.
antibiotic
dizziness
balance)
Out of reach
reach
abdominal

advent
aftertaste
API
authenticity
coating
common
Counterfeit
despite
elevated
Excipient
active substance.
fake
fatal
hay fever
industrialized
______ country
intestines
Pharmacopeia
pollen
enterprise
Nowadays, RRB is a research-driven,innovative pharmaceutical ___ that develops
new drugs, produces them, prepares them for sale, and markets them worldwide.
premises
______ is a place where company has its offices and/ or factories.
effervescent
_______ tablets are uncoated tablets containing substances that react in the presence
of water and give off carbon dioxide.
lab coat
__________ protects the scientist and the scientist's clothes from hazardous or hot
chemicals
rubber gloves
__________ protect hands from chemical compounds
Safety goggles
__________ are used to protect your eyes are you work in the lab such as chemical
splashes/spills.
corrosive
Please mind the _____ substances, which could cause severe burns.
hard hat
A _____ must be worn at all times in this area to protect your head.
polite
If you give instructions in a very direct way, it may not sound _____.
Safety
__________ is the freedom from danger or harm.
Security
__________is the protection from threats, such as attacks or crime.
dispenser
_____ is a machine/ mechanism which releases its contents in defined amounts.
drum
A __________ holds the pressed tablets until it is time to coat them.
Fluid bed dryer
The granules are air-dried in the __________.
coat
A drum holds the pressed tablets until it is time to ______ them
Excess powder remover

In the _________, As the tablets go up a spiral, they are shaken, and the excess
powder is vacuumed off. The pressed tablets are put into a drum and stored until it is
time to coat them.
Granulator
In the _________, the ingredients are mixed to create a wet mixture.
granule
The dried ____(s) are stamped into a mould to form tablets.
Hoist
Dry ingredients are weighed and transported to the granulator by the __________.
moisture
The ______ is removed by the hot air in the fluid bed dryer.
mould
The dried granules are stamped into a _____ to form tablets.
shaker
A __________ loosens the excess powder.
Sieve
The wet granules are pressed through a _________ on their way to the fluid bed
dryer.
Tablet press
The dried granules are stamped into a mould to form tablets in the __________.
vacuum
A __________ system sucks up the excess powder.
calibrate
Lab equipment should always be clean or sterile and ______(d) before using it.
comply with
Pharmaceutical companies have to ______ GMP guidelines
content weight
uniformity, ______, and so on.
guidelines
Pharmaceutical companies have to comply with GMP ____.
mix-up
Well, we have to make sure that there are no ______(s) (mistake) of materials
throughout the whole manufacturing process.
optimize
GMP covers how to design and construct buildings so that the flow of materials is
______(ed), and so that they can be cleaned easily.
reliable
In order to receive valid and _____ results, all devices and methods have to undergo a
validation process.
uniformity
_______, content weight, and so on.
humidity
_________ is the amount of water vapor in the air
blister pack
A(n) __________ is a type of single-use plastic container, and is used for
pharmaceutical products as well as for other consumer goods. The product is placed
in the formed cavity and sealed by lidding foil. The product is removed by pushing it
through the foil.
bottle
Which primary packaging is the most suitable for nose drops?
cap
contents are used up. Sometimes a desiccant is integrated into the ______ so that the
content
______(s) are used up. Sometimes a desiccant is integrated into the cap so that the
_______(s) remain dry.
desiccant
contents are used up. Sometimes a _____ is integrated into the cap so that the
disposable
A sachet is a small ______ bag containing an individual dose of the medicine. It often
has a lengthwise perforation which can be torn open.
foil
A blister pack is a type of single-use plastic container, and is used for pharmaceutical
products as well as for other consumer goods. The product is placed in the formed
cavity and sealed by lidding ______. The product is removed by pushing it through
the ____.
individual
A sachet is a small disposable bag containing a(n) ______ dose of the medicine. It
often has a lengthwise perforation which can be torn open.
Inhaler
A(n) __________ is an aerosol dispensing device which releases medication into the
mouth of the patient. The medication is breathed deeply into the lungs, or stays in the
mouth or throat.
jar
A(n) __________ is a multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be opened and closed several
times until the contents are used up. Sometimes a desiccant is integrated into the cap
so that the contents remain dry.
Primary packaging
__________ is the material which is in direct contact with the product.
sachet
A(n) __________ is a small disposable bag containing an individual dose of the
medicine. It often has a lengthwise perforation which can be torn open.
Secondary packaging
__________ is any packaging material that is not in direct contact With the product.
sticky label
A(n) __________ is a piece of paper attached with adhesive to the primary packaging
to identify it and give details concerning its ownership, nature, and/or use.
syringe
A(n) __________ is a needle attached to a plastic tube used for putting medicine into
the body or removing blood.
tube
Which primary packaging is the most suitable for ointments?
accessible
A lot of research is done to make packaging childproof,i.e. a child cannot open it
alone. However, at the same time, the elderly must have easy access to their
medication,i.e.it needs to be elderly-_______.
align
Slide container system is a container with three buttons that must be ____(ed) in
order to slide off the lid .
catch
______.
childproof
__________ means a child cannot open it alone.
closure
In a "push-screw" container system, a _______ must be pushed down before it can be
unscrewed.
elderly-accessible
The elderly must have easy access to their medication,i.e.it needs to be __________.
peel-push system (Container system)

A first layer must be peeled off a blister before the drug can be pushed through the
second layer.
poke (Container system)

catch.
push-screw (Container system)

A closure must be pushed down before it can be unscrewed.
slide (Container system)

A container with three buttons that must be aligned in order to slide off the lid.
squeeze-screw (Container system)

A closure must be squeezed between two fingers before it can be unscrewed.
anticipate
The boy's death highlighted a problem that no one had _______(d) up to that time .
community service
A mother was sentenced to several years' ________ for leaving a used medical patch
in a place where her young son could have access to it.
convict
If someone is ______(d) of a crime, they are found guilty of that crime in a law court.
demand
Because of her son's death, the young mother _____(ed) that safe-disposal boxes be
included in the packages of medicated patches.
discard
Safe-disposal boxes should be included in the packages of medicated patches. These
boxes should have a small slit at the top to _____ used patches and it should be
impossible to open them.
negligence
A few years ago, a mother was convicted of _______ leading to her son's death. ( =
Failure to take proper care over something/someone)
overdose
A few years ago, a mother was convicted of negligence leading to her son's death. It
was claimed that he had died from a pain medication _____.
pain relieving
A four year old boy was found dead after he had stuck a highly potent, ______ patch
to his leg.
SESSION 1
Topical Medicine is applied to a certain part of the surface of the body.
WNL If a function is ______ (Within Normal Limits), it is operating in a normal

range.
XR An X-ray is a visual image of all or part of the body acquired with special
equipment using electromagnetic radiation to see bones and other internal aspects of
the body.
BP (Blood Pressure) is the force exerted by circulating blood on the walls of
blood vessels. Lt is a vital sign that medical professionals use to determine whether
body systems are operating as they should.
c/o
Dx
Diagnosis) is the positive identification of a patient's disease or ailment.
HR
HTN
o/e
Rx
SOB
than usual.
T

drop (gtt)
gram (g)
gtt
microgram (mcg)
major component.
milligram (mg)
milliliter (ml)
centimeter.
ounce (oz)
three teaspoons.
teaspoonful (tsp)
five milliliters.
administer
dosage
I.V.
IM
P.0.
P.R.
SQ
syringe.
SL
administered
Nurse: Should that be _____ P.O. or through an injection?
Doctor: An IM would work better.
T
the amount of internal body heat measured
SOB
The asthmatic patient complained of _____
Rx
_____ for the infection included antibiotics.
c/o SOB
The doctor's note said that the patient _____. This is an abbreviated way of saying the
patient complained of shortness of breath
complained of shortness of breath

The doctor's note said that the patient c/o SOB. This is an abbreviated way of saying
the patient _____
BP
140/90
XR
_____ shows no acute lung disease
O/e
_____ patient appears to have high levels of anxiety
gtt
..... in eye.
a bad infection
This note calls for three drops in each eye twice a day. That seems a little
high.
That's right. They're a little higher than usual. Mr. Paul has _____.
subcutaneous
injected into the fatty layer under the skin with a syringe
sublingual
given beneath the tongue
Is the ____________________ for this medicine sublingual or P.O.?
administer
How should we ______________ Mr. Smith's medicine?
topical ointment
Ms. Gates received medicine in several different ways. First, she received a _____.
Later, she needed more serious medicine through an I.V. and intramuscular
injections.
antibiotic pills
When she was discharged, she received _____ to be taken P.O.
sublingually
Nurse: Okay, He'll want to take that _____, right?
Doctor: Yes, he can't chew tablets.
affected area
Ms. Gates came in complaining of a rash. She received a topical ointment to
administer to the _____.
arisen
Ms. Gate's persistent illness has been caused by an infection. Serious complications
have _____.
serious dehydration
Ms. Gates was admitted to the hospital with _____ and breathing trouble. She was
given fluids through an I.V.
given fluids
Ms. Gates was admitted to the hospital with serious dehydration and breathing
trouble. She was _____ through an I.V.
Ít khi saiCác đáp án gần đây của bạn hầu hết đều đúng!
Chọn 1
mEq, tsp, tbsp, g, mg, mcg
..... by mouth.
Đúng tấtBạn đã trả lời đúng hết rồi!

Chọn 26
c/o
to describe uncomfortable symptoms
Dx
the identification of an illness or disease
BP
the amount of force applied on blood vessel walls by circulating blood
HR
the number of heartbeats in a given amount of time
WNL
to be at an average level
o/e
discovered while investigating a patient's health
XR
The _____ clearly showed that bone was broken.
HTN
The patient with high blood pressure was diagnosed with _____.
T
100.6 degrees Fahrenheit, as taken by oral thermometer
HR
81 beats per minute
1 cc (1 cubic centimeter)
_____ is equal to one ml.
drops
Please put 2 _____ of cleaning solution in each ear. Use a dropper.
milliliters
Half a liter is equal to 500 _____.
ounces
There are sixteen _____ in a pound.
grams
One thousand _____ make up one kilogram.
P.O
taken orally, or through the mouth
P.R
taken through the rectum
I.V
injection into a vein using a syringe, often over a long period of time
topical
applied to a certain part of the surface of the body
I.M.
Please get me a syringe so I can give this _______________.
dosage
For this patient, the correct ______________ is 200 milligrams per day.
intramuscular injections
Ms. Gates received medicine in several different ways. First, she received a topical
ointment. Later, she needed more serious medicine through an I.V. and _____.
patients' meds
Doctor: Cindy, let's review these _____ before I head out.
Nurse: Sure thing, Doctor.
chew
Nurse: Okay, He'll want to take that sublingually, right?
Doctor: Yes, he can't _____ tablets.
topical ointment
Ms. Gates came in complaining of a rash. She received a _____ to administer to the
affected area.
rash
Ms. Gates came in complaining of a _____. She received a topical ointment to
administer to the affected area.
SESSION 2
current
The patient's _____ condition was caused by a recent injury.
muscle ache
a pain felt throughout the body
symptom
Fatigue is a _____ of the flu.
symptoms
I advised the patient that her _____ suggest flu rather than a cold.
Chọn 5
QID
given four times per day
Past Medical History

Previous medical problems, especially related to current condition.
medical histories
As a medical professional, you should be prepared to take thorough _____.
suffering from
You wrote on the form that you're _____ chest pain.
flu
Helen was coughing because of the _____.

Chọn 43
TID
given three times per day
QOD
given every other day
BID
given twice per day
PRN
given as needed
QH
given every hour
Stat
I need 50 cc's of lidocaine immediately!
qhs
You should take this antibiotic when you go to bed.
ac
The patient should take this medication before he eats.
qh
You will need to take a pill once every hour until you start to feel better.
pc
Take two of these after you eat.
ac
Nurse: Sure. And how often should he get those?
Doctor: They should be taken TID. Preferably _________, before they bring his food.
onset
the first instance of something

a record of a patient's family's conditions
data
a collection of information
allergy
a condition that causes a reaction or illness
procedure
a medical treatment
complaint
a pain or illness reported by a patient
history of
Paul's family has a _____ cancer.

The patient's _____ included her previous surgeries .
social history
The patient's _____ included her occupation.
Social History
Patient's personal habits and lifestyle
Family Medical History

Conditions likely to occur in a particular family history.
complaint - history of the condition

Get as many details as possible about a patient's _____. Find out if the patient has a
_____.
social history
A good _____ includes information about the patient's personal habits and lifestyle.

A _____ reveals conditions that are more likely to occur in a particular family.
medical procedure
Before any _____, make sure you have an updated record of the patient's allergies
onset of
Nurse: Do you remember when exactly the _____ the problem was?
Patient: Let's see. I think I first noticed it about six years ago.
a history of
Does anyone in your family have _____ heart problems?
runny
having liquid leaking from something
wheeze
to breathe noisily and with difficulty
headache
a pain felt in the head
cough
to force air loudly through the throat
cold
an illness that causes discomfort in the head and body
throbs
The pain in my back _____.
fever
According to the thermometer, the patient has a _____.
feel well
Doctor: What's the trouble today?
Patient: Well, Doctor, I don't _____ at all. I'm sure I have the flu.
blowing my nose
Doctor: And have you noticed that your nose is runny?
Patient: Oh, yes. I've been _____ constantly.
muscle aches
Doctor: Okay. Do you have pain throughout your body?
Patient: I do have _____. And I'm so tired that I can hardly do anything.
runny nose - coughing

She said she was treated for a cold last month by another doctor and she was worried
it might have returned. Once again, she has a _____ and is ______.
cold
She said she was treated for a _____ last month by another doctor and she was
worried it might have returned. Once again, she has a runny nose and is coughing.
fever
A temperature reading indicated a _____ of 102 degrees.
temperature
A _____ reading indicated a fever of 102 degrees.
analgesic
I recommended an over-the counter _____ to relieve pain and reduce the fever.
Thứ tự gốc
complaint
onset
cold
wheeze
ac
BID
pc
PRN
qh
qhs
QID
QOD
stat
TID
allergy
current
data
history of
repeatedly.

medical details.
procedure
social history
and marital status.
cough
irritation.
fever
flu
headache
muscle ache
runny
symptom
throb
SESSION 3
affect
auscultation
body language
evaluate
inspection
observation
palpation
percussion
pulse
vital signs
albumin
biopsy
blood pressure


time.
creatinine

pathology report
examined.
renal
urinalysis
CT scan
electrocardiogram
period of time.
endoscope
body cavity.
feed
pictures,
gel
probe.
medical imaging

radiography
ultrasound
x-ray
human body
vital signs
Things to check in an exam
Body Language (Kinesics)

palpation
Examination techniques
percussion
pulse
evaluating posture
Which of the following is NOT an aspect of checking vital signs?
to check the condition of internal organs

What is one use for percussion techniques?
Chọn 10
inspection
The doctor performed an investigation of the patient's ear.
evaluate
The nurse forgot to determine the quality of the patient's posture.
stethoscope
Use a _____ to conduct auscultation of the patient's breathing.
a general inspection of physical body parts

Check the arms, legs, back, and neck with palpation.
auscultation - percussion
Patient: Do you think something is wrong with my stomach?
Doctor: No. I just want to do some _____ and _____ tests to make sure. Take a deep
breath.
biopsy
We will remove some tissue from your liver during the _____.
GFR test
A ______ tests how well kidneys are working.
renal function
The family history includes kidney problems. This led me to check Mr. Reed's _____.
kidney disease
The combination of a low GFR rating and high BUN level
three-dimensional
A computer combines the X-rays into a _____ image. We can work with the image to
see many different things.

Chọn 41
auscultation
Observation
Through watching carefully the doctor noticed that the patient was limping.
affect
The patient's back pain seemed to make a difference upon her mood.
comfortable - optimal
The first step in conducting a physical exam is making sure that the patient is _____
and that the examination environment is _____.
4 steps
How many steps to physical examinations?
Physical examination
_____ is one of the most basic of medical care procedures.
oral thermometer
With the patient sitting, take his/her temperature using an _____.
auscultation
Use a stethoscope to conduct _____ of the patient's breathing.
palpation
Conduct a general inspection of physical body parts. Check the arms, legs, back, and
neck with _____.
excess abdominal fluid

Doctor: I'm going to tap right here on your stomach.
Patient: Why do you do that?
Doctor: This is a test to detect ______.
urine
a yellow liquid waste product that the body produces
renal
If one or both kidneys decline in function you may have _____ failure.
blood pressure
Your _____ reading, at 110/65, is on the low end of the normal range.
kidney
People can have a relatively normal life with just one _____.
pathology report
The ______ will show the results from several tests.
albumin - creatinine
There are very high levels of _____ and _____ in the patient's urine and blood,
respectively.
urine
There are very high levels of albumin and creatinine in the patient's _____ and blood,
respectively.
GFR low
When is a person get sick?
BUN high
When is a person get sick?
appetite
Mr. Reed complained of a decrease in _____. He also reported having less energy.
urinalysis
A _____ reveals a high level of albumin present in his urine.
renal failure
Mr. Reed likely has kidney disease that is progressing rapidly towards _____.
renal biopsy
A _____ should be scheduled as soon as possible to determine the cause of the
disease.
serious
Unfortunately, the results are _____. First, according to the GFR test, your GFR level
is 40.
kidney disease
Nurse: Unfortunately, the results are serious. First, according to the GFR test, your
GFR level is 40. It indicates a moderate case of _____.
ECG
Get a(n) _____ of that patient's heart activity.
gel
Apply this _____ to the area before using the ultrasound machine.
feed
The doctor will _____ a tube into the man's chest to see pictures with the endoscope.
X-ray
The bone is likely broken, but take a(n) ______ to make sure.
medical imaging
Modern technology provides many _____ techniques.
brain
Suzanne, we're going to start off by taking an X-ray of your _____. Maybe that will
show the cause of your headaches.
headaches
Suzanne, we're going to start off by taking an X-ray of your brain. Maybe that will
show the cause of your _____.
a patient who is pregnant

Who is most likely to be examined by an ultrasound?
X-ray
Which of the following is NOT an advanced medical imaging technique?
Unborn children
_____ are often examined through ultrasounds.
endoscopes
A doctor feeds a tube with a tiny camera on its end directly into the organ or cavity to
be examined.
MRI
_____ utilizes the magnetic properties of atoms to create very detailed pictures.
ECG
_____ measures the electrical activity of the heart.
Radiography
_____ is the use of X-rays to take pictures of the internal body. It is a common
imaging technique used in many different situations.
CT scan
_____ is an advanced form of radiography. It uses many different twodimensional X-
rays to create a threedimensional image.
ultrasound
_____ uses the reflection of sound waves to create images. A special gel placed on
the skin aids this process.
SESSION 4
advertisement
Clinical Affairs
compound
the patients.
drug authority
drug documentation
effective
Ingredient
market
Marketing and Sales

Production
promotion

Regulatory Affairs

Analgesic
apply for
Colleague
conclusion
encouraging
launch
Liaise
marketing claim
memo
on board
______
pipeline
Preclinical data
trials.
Prescription
from the doctor.
determine
Feasibility study
investigation
powder
practicality
profitability

cross-functional
deadline
Medical writer
medication
meet requirements
oily
Ointment
production line
Project manager
launch a drug.
Qualified person
Health regulations
adverse
develop
health authority
operate
pharmaceutical
assigned to

organization.
conceptual design
degree
deliverables
expertise
licence
methodology
B.S.
BSc
MS
MSc
cost estimate
the month.
finalize
milestone
accurate
analytical testing

anti-depressant
cheerful
considerably
authorities allow.
consultant
cough
cough syrup
Cross-cultural
cure
interesting.
custom
imperfection
packaging
remedy
Self-medicate
Subsidiary
Thông số của bạn

Thường SaiCác đáp án gần đây của bạn hầu hết đều không đúng!
Chọn 1
formulation
The term that does NOT fit in "What goes into drugs"?
Đôi lúc SaiCác đáp án gần đây của bạn đôi lúc đúng, đôi lúc sai.
Chọn 10
Feasibility study
an investigation to determine the advantages, practicality, and profitability of a
proposed project.

When a company starts to test drugs on live subjects, I work closely with the doctors
to make sure that the studies are done correctly.
My job is to make sure that suitable, clean containers are used to get the product from
the company to the patient. In general, I check for compliance with health
regulations.
tested
New drugs are _____ on live subjects.
perform - interpret
Clinical research associates _____ clinical trials. They must also summarize, _____
and process clinical data.
research
I did _____ on clinical methodology.
the team
I was on _____ that developed the new dosage form for this medication.
line worker
The term that does NOT fit in "Non-production pharmaceutical professions"?
prescription drug
The term that does NOT fit in "Dosage forms"?
clinical research associate, formulation scientist, laboratory technician,

pharmacovigilance manager
"Non-production pharmaceutical professions" included?

Chọn 59
Production department
We compound the raw materials into drugs, package them, and put in the leaflets for
the patients. We also keep careful records of all the steps in this process.
Research & Development

We find new substances to make new drug formulations or change existing dosage
forms, for example, from tablets to capsules.
Regulatory Affairs
We compile the drug documentation and send it to the drug regulatory authorities so
we can get authorization to market the product.
Marketing and Sales

We plan the promotion and distribution of drugs which will be launched, and make
decisions about the packaging or colour of new products.
Clinical affairs
We test or organize testing on live subjects, and make sure that our drugs are safe and
effective for the patients.
Quality assurance
We ensure that products meet the standards which the law requires, and contain the
active ingredients advertised.
Dosage form
the final form of the medicine, e.g. Tablet, powder, gel, spray, etc.
Over-the-counter drug
a product which can be sold without the patient seeing a doctor
Products in the pipeline

future drugs, not yet on the market.
Prescription drug
Medicine bought in a pharmacy and requiring a written note from the doctor.
I collect drug safety information about patients on our medications. I must report any
serious adverse events to the health authorities.
Medical writer
It's my job to research, write, and edit clinical and study reports before we submit
them to regulatory authorities. I summarize and interpret clinical data .
Project manager
I co-ordinate and manage the cross-functional teams that develop and launch a drug.
It's not easy to get people to meet deadlines.
Qualified person
I am personally responsible for the quality of each product that leaves the production
line. I must manage all the processes in production, QA, and the labs to make sure
Standard Operating Procedures are followed.
In my work, I develop pharmaceutical dosage forms. At the moment, I am changing a
tablet formulation into ointment and gel forms.
Ingredients
a substance in a drug
On our medication
taking our medicine
Standard Operating Procedures

a description of a working method or process
Subjects
a human or animal drugs are tested on
Adverse events
any health problem which starts while on a new medicine
Health regulations
rules or laws about health
Ointment
an oily substance like a cream
report
Companies must _____ serious adverse events to the health authorities.
operate
Laboratory technicians ______ complex scientific instruments and DETERMINE /
PERFORM whether liquids, powders, or tablets meet requirements.
submits
Regulatory Affairs _____ documents to regulatory authorities.
originally I come
I am American, but _____ from Vietnam.
am based at
I _____ our manufacturing plant in Shanghai.
professional background
My ______ is in pharmacology.
received
I _____ my master's degree at New York University.
worked for
I _____ Pharmafix in their R&D department and later for Johnson & Johnson.
started as
I first _____ a line worker and worked my way up to packaging technician.
experience in
I have _____ marketing new analgesics, so that is why I was asked to join this
project.
involved
I was _____ in the planning and building of our new pharmaceutical facility in
Shanghai.
responsible
I am _____ for the planning and building of our new facility in Shanghai.
supported
I am _____ by two clinical research associates who will work with test centres in
northern Italy
working
We are currently _____ on the other two dosage forms.
working
At the moment, I am _____ on a project to build a new analgesics production line.
to review
Before we close, I'd like _____ the action points.
to finish
Walter is _____ the other dosage forms by the end of the month.
looking after
Charley's team will be _____ the new equipment needed.
get back
Each department head needs to _____ to me by Friday.
searching
CRO is _____ for someone to co-ordinate and perform analytical testing for stability
assist
You will _____ in the management of clinical drug development.
responsible
You will be _____ for recruiting investigators and collecting s study documentation
essential
It is _____ to this job to use a wide variety of physical and chemical analyses to
support shelf-life studies of patented pharmaceutical products.
is searching for
CRO _____ someone to co-ordinate and perform analytical testing for stability
responsible for
You will be _____ checking laboratory documentation and chemical specifications.
year's experience
You should have at least three _____ in pharmaceutical analytical techniques and test
methods.
required - preferable
At a minimum a BS in Chemistry or a related science is _____, an MSc is _____.
marketing claims
The term that does NOT fit in "Pharmaceutical documentation"?
capsules, gel, ointment, sugar-coated tablets

"Dosage forms" included?
chemicals, ingredient, raw materials, substances

"What goes into drugs" included?
clinical reports, dossiers, protocols, study reports

"Pharmaceutical documentation" included?
in-pharmacy training programmes

when foreign companies try to introduce drugs here, we ask them for good
__________ because our staff will have to answer many questions before people are
willing to buy such cures.
scratch - imperfection
We will reject a whole shipment of drugs if we find the smallest _____ or _____ in
one single package.
self-medicate
US patients tend to ______ and buy drugs online.
anti-depressants
you'll also find many cheerful, bright coloured ads in magazines, which promote
_____.
side effects
The next page is always full of all the warnings, possible _____ and things to ask
your doctor about.
SESSION 5

Chọn 7
Pharmacokinetics
Dose
breathe in
device
of the patient.
Behind-the-counter
incidence
involvement

Chọn 84
beneficial effect
carry forward
Clinical trial
Development
discovery
Research
breakthrough
chew
New chemical entity

Obtainable
prescription only)
occasionally
occur
palpitations
Bioavailability
Chewable tablet
drug administration
harmful
antidote
Chemist
composition
expert
First in-man study

beings.
Formulation
specific purpose.
Pharmacodynamics
pharmacologist
Pharmacology
Pharmacokinetics.
poison
Toxicity
or animals.
Toxicologist
Toxicology
Dosage
safely.
Dosage form
Effervescent tablet
liquid
Pill
into the body.
Ailment
Allergic reaction
agent.
anaemia
Asthma
Bronchitis
Chronic
Diabetes
(glucose).
Diarrhoea
Eye drops
favour
Fever
usual.

Indigestion
Inhaled
Inpatient
treatment.
Insomnia
Lotions
Lozenge
Nasal spray
Nausea
vomit.
Ointments
healing.
Oral drops
Oral solution
Patch
Pneumonia
Septic

Sublingual tablet
aerosol
dissolve
Gel
Liniment
melt
rectum
Suppository
Syrup
Tablet
Topical
apply
of pain.
Over-the-counter
abuse
adequate
effective use.
directions
do harm
must be avoided.
margin of safety
use.
misuse
policy
dosage form
Mensamint is a new ______ of Mensadent.
Toxicology
The science of poisons, including their source, chemical composition, action, tests,
and even their antidotes, is what we call _____.
suppository
We often use a __________ to administer medication to babies or other patients who
are not able to take drugs orally.
Chọn 18
new chemical entity
A _____ has just been synthesized in our own labs, which we think may be useful in
our Mensapatch development plans.
brainstorm ideas
A meeting will be held tomorrow at 9.30 a.m. in conference room 308 to _____ for
this new substance, and to discuss the further development.
formulation
The _____ for adult patients is in lozenge form.
indication
The _____ is to stimulate brain activity and thinking power.
Prescription
If a drug or medicine is not available 'over-the-counter', it normally means that a
_____ from a physician is needed to obtain it from a pharmacy.
formulation
Chemists and pharmacologists are also interested in how the medicine is
administered, so they often ask about its _____.
First in-man study

Before drugs or medicines can be made available to the public, they have to be tested
on human beings. We call this an _____.
Pharmacology
_____ is the study of drugs, how they work, and what they do in the body.
What kind of formulation could we develop from this NCE?

It is already available in lozenge and chewing gum form, but we hope to develop a
time-release patch in the near future.
Are we in a position to make this new dosage form with our current technology?
Not completely. However, we do have a partner to help us develop a patch form
which provides the desired effects for at least six hours.
What do you think about...?

_____ the new drug which has recently been developed to cure heart disease?
A new drug has recently been developed to cure heart disease.
What's your opinion on...?

_____ whether a pill or patch dosage form should be considered?
More than one dosage form is being considered: pill, and patch.
dosage
Calculating the correct __________for some patients isn't always easy.
pills, tablets
Children and older people often have trouble swallowing large __________ or
__________.
drops
A very small amount of liquid that forms a round shape.
Behind-the-counter drug
can be purchased without a prescription but only with the personal involvement of a
pharmacist..
four criteria
Medication must meet _____ in order to obtain the status of a non-prescription or
over-the-counter (OTC) product
a large margin of safety,

low incidence of side effects,
low potential for drug abuse,
labelling that provides adequate directions for sale and effective use.
Four criteria to obtain the status of OTC in the US:

Chọn 27
Research
The process of testing chemical compounds, with the goal of finding a substance
which has a beneficial effect on a targeted disease.
Development
the process of carrying forward scientific discoveries made during the research
process, with the goal of producing a marketable drug.
obtainable with
Mensadent _____ physician's prescription only.
physician's prescription
Mensadent obtainable with _____ only.
side effects
Known _____ often include loss of sleep if taken in the late afternoon or evening.
chemist
A specialist or expert in the scientific field of chemistry is called a _____.
Dosage form
Using the right _____ is especially important when giving medicine to children,
because they often have problems swallowing pills.
Pharmacodynamics and Pharmacokinetics

Pharmacology can be divided into two separate areas:
Pharmacodynamics
studies what the drug does to the body
Pharmacokinetics
studies what the body does to the drug
Is there some information available on the toxicity of the substance?

intravenous routes of drug administration for this NCE.
What kind of time frame are we talking about for the first in-man study?
I'm afraid it may take a year or more before we can start the first tests on healthy
humans.
I'm convinced
_____ this new formulation will be successful.
I'm afraid
_____ I don't have enough information to make a statement on that.
patch
Wearing a __________may create problems for people with skin allergies.
drops, syrup
Some medications are available in liquid form, such as __________ or __________.
ointment
An smooth, thick substance to rub on the skin for healing.
liniment
An oily liquid to rub on painful body parts to reduce pain.
patch
A medication on material or cloth placed on the skin
pill
A small, round piece of medicine to be swallowed without chewing.
aerosol
A container with a liquid that is administered in spray form.
solution
A liquid in which another substance has been dissolved.
suppository
A solid medicine which melts slowly in the rectum or vagina.
syrup
A sweet, liquid medicine taken with a spoon or cup.
inhaler
A small device with medicine to breathe in through the mouth.
Over-the-counter drug
a product which can be sold without the patient seeing a doctor.
Prescription drug
the medicine bought in a pharmacy and requiring a written note from the doctor.
What is the bioavailability of this NCE?

intravenous routes of drug administration for this NCE.
SESSION 6
in compliance with
standards.
interim testing
annual
auditor
disinfect
animals.
experiment
animals.
claim
contamination

Chọn 94
GAP
GCP
GDP
GLP
GMP
GRP
GSP
accuracy
adhere
Audit
beyond
compliance
company standards.
documentation
Endpoint testing
ensure
standards.
functional

Holistic approach
inspection
involved in
maintain
manufacturing
operation
operational
performance
______ and results
Procedure
company standards.
process
Product sampling
proper

to enable
Validation

Contaminated
manufacturer
Product recall
pure
Quality assurance
Quality control
Traceability
advise
assure
procedures.
confirm
internal
receipt
action
CAPA
Corrective action
deviation
focus
occurrence
Preventive action

recurrence
corrective action).
advance notice
categorize
minor, or critical.
Checklist
double-check
Finding
minor, or critical.
non-compliance
observe
Safety procedures
guaranteed.
up-to-date
Overshoes
pain relief
Eye bath
contamination.
Fire blanket
follow-up
Gas mask
improper
cage
covered
dispose
accordance with
biological agent
bio-safety cabinet
bleach
________ .
clarify
in more detail.
disinfectant
animals.
equipment
goggles
hazardous
protective clothing
bacterial
risks.
cause
complaint
container
danger
disposal
due to
force
Genotoxic substance
cancer.
global
Odour
Good sanitary hygiene

_____ must be practised by all lab staff.

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Chọn 1
Good sanitary hygiene
_____ must be practised by all lab staff.
Chọn 7
Standard operating procedures
(SOPs) are a set of written instructions to maintain performance and results.
Non-compliance areas improper documentation

Auditors' observations no recording of experiment times
Non-compliance areas improper hygiene after handling animals

Auditors' observations hand-washing or sanitizing forgotten
Protective clothing
______ must be worn in the labs at all times.
Lab animals
______ must be transported in covered cages.
Eye protection
______ must be worn as signposted.
must be carried out

Proper safety procedures _____ by laboratory staff.

Chọn 49
abbreviation
GxP is an _____ for good practice.
Auditing
Good _____ practice. (GAP)
Clinical
Good _____ practice. (GCP)
Documentation
Good _____ practice. (GDP)
Laboratory
Good _____ practice. (GLP)
Manufacturing
Good _____ practice. (GMP)
Research
Good _____ practice. (GRP)
Safety
Good _____ practice. (GSP)
Quality assurance (QA)

involves all manufacturing processes. QA makes sure the products are kept at high
standards and standard operating procedures (SOPs) are followed. QA includes
product: quality control, sampling, and testing.
Quality control
involves interim testing and product sampling procedures, which are carried out to
check product quality.
Endpoint testing
is carried out at the end of every manufacturing process to maintain quality standards.
Documentation
is important at every step involved in drug manufacturing
Prevent product contamination

Documentation is important at every step involved in drug manufacturing, because:
Internal audit
includes inspection and validation of all operational methods, procedures, and
equipment to ensure: Functionality, Accuracy, Validity.
Functionality, Accuracy, Validity.

Internal audit includes inspection and validation of all operational methods,
procedures, and equipment to ensure:
holistic approach
A _____ looks at all aspects of a pharmaceutical company together to make sure that
the entire process meets high industry standards.
Documentation
Which aspect of drug manufacturing NOT enables traceability?
traceability
the _____ of a drug.
holistic approach
A _____ considers laboratory and manufacturing processes and environments
together and not individually.
assurance
Quality _____ involves all manufacturing processes in GMPwhich make sure the
control
Quality _____ involves interim testing and product sampling procedures, which are
carried out to check product quality.
endpoint testing
At the end of every stage of a product's manufacturing process, accuracy _____ is
done to maintain quality standards.
product recall
market in a _____ if serious adverse reactions occur.
validation
Manufacturing processes and procedures must go through periodic _____ to
Contaminated products
___________ are no longer pure and acceptable for sale or public use and, therefore,
must be returned to the manufacturer, or destroyed.
Compliance and Non-compliance

The audit finding can be classified into 2 groups:
major, minor, critical.

"Non-compliance" is categorized as either _____
Corrective Action/Preventive Action (CAPA)

is a part of Quality Management System (QMS), it focuses on the systematic
investigation of errors or deviations.
prevent occurrence of errors

Preventive action (PA):
prevent recurrence of errors

Corrective action (CA):
timetable
The _____ for the various laboratory audits is as follows:
Laboratory 1: Tuesday and Wednesday
Laboratory 2: Wednesday and Thursday
Laboratory 3:Thursday and Friday
audit checklist
Two members of our audit team will begin this internal audit on Tuesday, two weeks
from tomorrow, using the latest company approved _____.
is to advise you
This memo _______ that your department has been scheduled for a periodic audit of
laboratory safety systems & procedures.
Our goal
__________ is to identify and correct any quality system defects and to assure
compliance with industry standards, especially for laboratory procedures.
will be reviewed
The completed checklist and original audit results _________ with you and the
Director of Laboratory Management, to identify areas requiring corrective or
preventive action.
short
Advance notice of this meeting was very ____________ .
safety
____________ procedures make sure that the health and well being of laboratory
workers are guaranteed.
observe
Auditors generally watch or ____________ safety procedures in the lab.
checklist
procedures, auditors use a ____________ .
non-compliance
If any ____________ is observed during the audit, the department will be informed
so they can take corrective action.
updated
Standard operating procedures (SOPs) are ____________ on a regular basis, often
after an audit has been carried out.
up to date
to stay ____________ in their scientific fields.
finding
Any observation or ____________ noted by the auditors is categorized as either
major, minor, or critical.
Non-compliance areas improper disposal of toxic waste
Auditors' observations chemicals found in normal waste bins
Non-compliance areas improper transportation of lab animals

Auditors' observations lab mice moved outdoors in open cages
Non-compliance areas improper clothing/safety equipment

Auditors' observations safety gloves too big, no safety goggles
All toxic waste materials

_____ must be disposed of properly.
must be worn
Proper protective clothing and safety equipment _____ at all times.
must be disposed of
Toxic or hazardous materials ______ properly.
Enable traceability -> full product recall

Documentation is important at every step involved in drug manufacturing, because:
SESSION 7
Creams
act on
administer
clinical
CMC
in vitro
in vivo
obtain
organism
potency
formulated drug.
potential
commence
intention
end of the year.
appropriate
authorization


products
concentration
Control group
impromptu
advance.)
Preclinical studies
abnormality
appearance
day
behaviour
consumption
dosegroup.
observation
Absorption
blood.
approval
benefit-risk
disorder
part.
Distribution
effectiveness
evaluate
Excretion
exposure
gather
healthy
indication
marketing approval
Metabolism
Metabolites.
Phase I
Phase I
Phase II
take part.
Phase II
dose.
Phase III
drug.
Phase III
Phase III
Phase IV
Phase IV
abnormal
Adverse event
causal relationship
evidence
medicinal
placebo
preliminary
effective.
response
Adverse reaction
affect
Briefly
Disease
Effect
right away.
Illness
Sensible
cancel the trial.
Sensitive
Shortly
authority
cancer
court
efficacy
experimental drug
fall victim to
legal right
experimental drugs?
misconception
randomly
rigorous
SESSION 8
dossier
Drug Safety
physician's report.
monitor
Pharmacovigilance
Regulatory Affairs
accompanied
and agitation.
Adverse event
agitation
blood pressure
confusion
consciousness
contraceptive
she has sex.
discharge
experience
history
hospitalization

Side effect
Vital signs
attending physician
correlation
dizzy
faint
Hypertension
140/90)
Hypotension
65/70).
Inflammation
Irritation
Itching
Rash
sedative
case report
in a ______.
Allergic
allergy
concomitantly
pill and Mensamint.
emotional
hospital admission
EMEA
products.
FDA
consumers.
MHRA
QPPV
disprove
inconclusive
ruled out.
compile
confused
leaflet
information _____.
quality.

PILs'
alarm
brief
by QA
conduct
France.
differentiate
frequent
patient compliance
Active substance
consult
medicine.
frequency
high-profile
famous)
jargon
or industry.
preservative
probability
effects.
antibiotic
dizziness
balance)
Out of reach
reach
abdominal

advent
aftertaste
API
authenticity
coating
common
Counterfeit
despite
elevated
Excipient
active substance.
fake
fatal
hay fever
industrialized
______ country
intestines
Pharmacopeia
pollen
SESSION 9
Creams
act on
administer
clinical
CMC
in vitro
in vivo
obtain
organism
potency
formulated drug.
potential
commence
intention
end of the year.
appropriate
authorization


products
concentration
Control group
impromptu
advance.)
Preclinical studies
abnormality
appearance
day
behaviour
consumption
dosegroup.
observation
Absorption
blood.
approval
benefit-risk
disorder
part.
Distribution
effectiveness
evaluate
Excretion
exposure
gather
healthy
indication
marketing approval
Metabolism
Metabolites.
Phase I
Phase I
Phase II
take part.
Phase II
dose.
Phase III
drug.
Phase III
Phase III
Phase IV
Phase IV
abnormal
Adverse event
causal relationship
evidence
medicinal
placebo
preliminary
effective.
response
Adverse reaction
affect
Briefly
Disease
Effect
right away.
Illness
Sensible
cancel the trial.
Sensitive
Shortly
authority
cancer
court
efficacy
experimental drug
fall victim to
legal right
experimental drugs?
misconception
randomly
rigorous

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WNL

If a function is ______ (Within Normal Limits), it is operating in a normal range.

cubic centimeter (cc)

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peel-push system (Container system)

poke (Container system)

push-screw (Container system)

slide (Container system)

squeeze-screw (Container system)

cubic centimeter (cc)

family medical history

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magnetic resonance imaging

Marketing and Sales

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Research and Development (R&D)

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clinical research organization (CRO)

New chemical entity

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Hard gelatin capsule

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patient information leaflet

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peel-push system (Container system)

poke (Container system)

push-screw (Container system)

slide (Container system)

squeeze-screw (Container system)

Topical Medicine is applied to a certain part of the surface of the body.

WNL If a function is ______ (Within Normal Limits), it is operating in a normal