ENGLISH FOR PHARMACEUTICAL PURPOSES – CREDITS 7 & 8

VIETNAM UNIVERSITY OF TRADITIONAL MEDICINE

DEPARTMENT OF FOREIGN LANGUAGES – ENGLISH GROUP
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SAMPLE TEST 1

I. Choose the best answer A, B, C or D to complete the following sentences. (15)

1. The practice of making sure that …………… and services fulfil defined standards is called the
……………
A. goods/ quality assurance B. substances/ compliance
C. substances/ prescription D. goods/ GMP
2. In order to get approval to sell a new drug, a company has to compile detailed documentation with
all the information required by the …………….
A. regulatory affairs B. SOPs
C. drug authorities D. QA
3. Some of the work the lab technicians do for the production department includes various
……………. during the process
A. interim analyses B. safety protections
C. active material creations D. contamination tests
4. In the PIL, basically for side effects that are ……………., you don’t just use “this lead to”. Instead,
say “this may, might, or can lead to”. However, in the case of ……………. side effects and real
warning, it is really necessary to be direct.
A. not common/ common B. common/ not common
C. not common/ rare D. unwanted/ real
5. …………… in clinical trials is a good way to …………… some extra money.
A. To participate / earn B. Participating/ spend
C. To participate/ spend D. Participating/ earn
6. …………… to humans are determined in toxicity studies.
A. Extensive documentation B. Clinical trial
C. Intended drugs D. Potential risks
7. Phase I Trials are done to find out how the drug …………… in the body.
A. works B. respond C. reacts D. all of the above
8. In the preclinical stage of drug development, an investigational drug …………. extensively in the
laboratory.
A. would be B. must be tested C. have to be tested D. ought to
9. The active ingredient can be tested in humans only after preclinical tests have been successfully
completed and …………… has been given.
A. documentation B. permission C. information D. authorization
10. Some of her symptoms are known …………… of Mensamint: loss of sleep if taken in the late
afternoon or evening, increase in blood pressure, heart palpitations, and headaches.
A. unwanted occurrence B. side effects
C. intended reactions D. All are correct
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11. We need to remember that not only healthcare ……………. read these PILs, but also …………….
A. pharmacists/professionals B. patients/ patient’s family
C. professionals/ patients D. doctors/ technicians
12. When using PogoloxTM, tell your doctor right away if your ……………. continues to rise.
A. pulse B. breath C. temperature D. high blood pressure
13. Please remember that the overshoes are only allowed to touch the …………….
A. white area B. black area C. color area D. All are correct
14. Regulatory agencies require testing that …………… the characteristics and chemical composition
of the API and …………… drug
A. document / formulation B. documents / formulated
C. writes / formed D. note down / formulary
15. A(n) ……………. is a piece of paper attached with adhesive to the ……………. to identify it and
give details concerning its ownership, nature, and/or use
A. sticky label / primary packaging B. syringe/ secondary packaging
C. sachet/ primary packaging D. blister pack/ secondary packaging

II. Read the sentence and decide if it is True (T) or False (F) by choosing the answer A or B. (5)
1. All laboratory work must be documented in accordance with GLP.
A. T B. F
2. According to the names of health authorities and terms used in pharmacovigilance, EMEA stands for
European Medicines Agency.
A. T B. F
3. It is absolutely essential to move lab mice outdoors in
A. T B. F
4. The quality assurance process in good manufacturing practice includes product quality control,
enables traceability, and testing.
A. T B. F
5. In preclinical trials, there are at least two different animal models. They are rodents and animals
which have systems more similar to human.
A. T B. F

III. Read the text and choose the answer A, B, C or D to fill in the blanks with missing
information.

The primary job responsibilities of Pharmacovigilance professionals are to provide product/drug safety
data and documentation. Pharmacovigilance professionals are qualified drug safety specialists.  One
particular area of their work includes performing a lot of functional responsibilities like safety trend
analysis, maintaining adverse reaction data, keeping global safety databases updated and conducting
safety training.

Pharmacovigilance is a pharmacological science that helps us to better evaluate the undesired effects of
drugs, report “them” to the applicable authorities and thus help in ensuring that only safe drugs stay in
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the market. For that reason “it” is an extremely important job function. Pharmacovigilance
professionals gather adverse drug reactions and safety data from people who have experienced an
adverse effect, healthcare providers like physicians as well as hospitals.

1. Providing product/drug safety data and documentation are ……………. of Pharmacovigilance

professionals.
A. main essential functions (A) B. job responsibilities (B)
C. Neither A nor B is correct D. Both A and B are correct
2. Pharmacovigilance professionals are …………….
A. drug safety specialists B. qualified drug safety specialists
C. qualified specialists D. specialists
3. There are ……………. examples of functional responsibilities performed by Pharmacovigilance
professionals.
A. two B. three C. four D. five
4. The word “them” in paragraph 2 refers to …………….
A. pharmacovigilance B. pharmacological science
C. the undesired effects of drugs D. the applicable authorities
5. The word “it” in paragraph 2 refers to …………….
A. pharmacovigilance (A) B. pharmacological science (B)
C. Neither A nor B is correct D. Both A and B are correct

IV. Read the text below and choose ONE suitable word from the given ones to fill in each
numbered blank.

organisms rats relationship used humans

toxicology scientific means refers substances
The dose of the substance is an important factor in toxicology, as it has a significant (1) relationship…
with the effects experienced by the individual. It is the primary (2) means of classifying the toxicity
of the chemical, as it measures the quantity of the chemical, or the exposure to the substance. All (3) …
substances…… have the potential to be toxic if given to living (4) …organisms……… in the right
conditions and dose.
LD50 is a common term used in (5) …toxicology……… , which (6) ……refers……… to the dose of
a substance that displays toxicity in that it kills 50% of a test population. In (7) ……scientific………
research, (8) ……rats……… or other surrogates are usually (9) ………used…… to determine toxicity
and the data are extrapolated to use by (10) ………humans……. (119 words)

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 ENGLISH FOR PHARMACEUTICAL PURPOSES – CREDITS 7 & 8

VIETNAM UNIVERSITY OF TRADITIONAL MEDICINE

DEPARTMENT OF FOREIGN LANGUAGES – ENGLISH GROUP
-----------***------------

SAMPLE TEST 2

I. Choose the best answer A, B, C or D to complete the following sentences. (15)

1. In the tablet production process, ……………. are dried by a strong flow of hot air.
A. granules B. excess powder C. pressed tablets D. dry ingredients
2. The skull-and-crossbones symbol is today generally used as a warning of danger, particularly in
regard to …………….
A. poisonous substances B. corrosive substances
C. radioactive materials D. raw substances
3. Nowadays, RBP is a research-driven, …………… pharmaceutical enterprise that develops new
drugs, produces them, prepares them for sale and …………… them worldwide.
A. innovatively/ tells B. innovatively/ promotes
C. innovative/ presents D. innovative/ markets
4. Finally, in the PIL, we put general information, ……………. the name and address of the
pharmaceutical company producing the drug in the “…………….” section.
A. such as / Further Information B. so as/ Further Information
C. such as/ What the product is D. so as/ What the product is
5. Volunteers …………… a big contribution ……………. the field of medicine, no matter what their
motivation is.
A. take/ in B. have/ in C. give/ to D. make/ to
6. …………… there were no clinical findings in the mid-dose group, the high-dose group animals
…………… clinical symptoms.
A. However/showed B. While/ showed
C. Furthermore/was showed D. Not only/ was showed
7. Despite more international co-operation in the fight to stop ……………. drugs, some countries have
unfortunately not taken …………….
A. artificial/ action B. fake/ activity
C. counterfeit/ action D. synthetic/ activity
8. ……………. are Primary packaging materials.
A. Inhaler, sachet and sticky label B. Inhaler, blister pack and syringe
C. Inhaler, sticky label and jar D. All are not correct
9. An open day allows pharmaceutical companies to be more transparent about their ……………
A. animals tested policies B. animals tested policy
C. animal testing policies D. animals testing policy
10. In a controlled study, one group of test subjects is exposed to the substance, while the ……………
is not.
A. treatment group B. uncontrol group
C. experimental group D. control group
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11. Clinical Study Reports are documentations about …………….

A. clinical trials and post-marketing information
B. clinical data, quality and post-marketing information
C. clinical and non-clinical trials and pharmaceutical documentation
D. clinical reports, pharmacology and testing data
12. A …………… group in preclinical studies is a group of test animals that is not exposed to the
medication under study.
A. experimental B. subject C. control D. treated
13. In phase II trials, testing determines the safety and …………… of the drug in treating the condition
and …………… the minimum and maximum effective dose.
A. efficient/ establish B. effect/ established
C. efficacy/ establishes D. efficacious/ establish
14. A drug …………… to act on the skin can be …………… as a cream.
A. intend / provided B. intended / formulated
C. intension / conducted D. intending / determined
15. As to her emotional state after hospital admission, the patient showed …………… of hyperactivity,
accompanied by confusion and a feeling of ……………
A. evidence / agitation B. proof / tired
C. witness / appetite D. clue / bored

II. Read the sentence and decide if it is True (T) or False (F) by choosing the answer A or B. (5)
1. Side effect is any intended reaction caused by a drug or medical treatment
A. T B. F
2. Drops is a sweet, liquid medicine taken with a spoon or cup. (syrup)
A. T B. F
3. Drug Safety Department is responsible for submitting documents needed to obtain marketing
approval for a drug. ( Regulatory affaie department)
A. T B. F
4. The results of clinical testing which used by experts in pharmaceutical method to determine how to
best formulate the drug for its intended clinical use are called Chemistry, Manufacturing and Controls
(CMC).
A. T B. F
5. My recommendation is to review with all lab staff the procedures for recording experiments.
A. T B. F

III. Read the text and choose the answer A, B, C or D to fill in the blanks with missing
information.

New medicines require testing because researchers must measure both the beneficial and the harmful
effects of a compound on a whole organism. A medicine is initially tested in vitro using tissues and
isolated organs, but legally and ethically “it” must also be tested in a suitable animal model before
clinical trials in humans can take place.
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Testing on animals also serves to protect consumers, workers and the environment from the harmful
effects of chemicals. All chemicals for commercial or personal use must be tested so that their effect on
the people and animals exposed to them is understood. The chemicals that we use day-to-day can
accumulate in the water, ground or air around us, and their potential impact on the environment must
be researched thoroughly.

1. New medicines ……………. testing because researchers must measure both the beneficial and the
harmful effects of a compound on a whole organism.
A. need B. are in need of C. require D. All are correct
2. The word “it” in paragraph 1 refers to …………….
  A. organ B. a medicine C. vitro D. tissue
3. Before clinical trials in humans can take place a medicine is initially tested in …………….
A. a test tube (A) B. living organisms (B)
B. Both A and B are correct D. Neither A nor B is correct
4. Animal experiments are widely used to test …………….
A. new medicines (A) B. new chemical for commercial or personal use (B)
B. Both A and B are correct D. Neither A nor B is correct
5. The potential impact of the chemicals that we use day-to-day on the environment must be researched
thoroughly because they ……………. in the water, ground or air around us.
A. gather together B. assemble
C. gradually increase in amount D. All are correct
 
IV. Read the text below and choose ONE suitable word from the given ones to fill in each
numbered blank.

basis characteristics component from relationship

products preparation storage stability depends

Packaging is an important (1) …compontent………… in the development of various drug

formulations in pharmaceutical industry. Packaging of pharmaceutical dosage forms has a close (2)
relationship… between a pharmaceutical (3) ……preparation… and its package which is a major
concern to the drug (4) ………stability … and safety. The selection of packaging material is made on
the (5) ……basis…… basis of its efficacy and performance characteristics in preserving the quality,
potency and safety of the pharmaceutical (6) …products. The stability of a drug in solid and liquid
dosage forms (7) depends… on the efficacy of the packaging materials to protect the drug (8) ………
from… chemical degradation and changes in physical (9) ……characteristics…… This is
particularly necessary for the (10) ……storage…… of the products under accelerated conditions. (113
words)