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Tuần 1 tuan 4,5,6 bài quizz

1. A unit of weight equal to 1/16th of a pound ounce (oz)

2. A unit of liquid volume equal to one thousandth of a liter and equal to one cubic
centimeter milliliter (ml)

3. a unit of mass equal to one millionth of a gram : microgram (mcg)

4. If a patient c/o (complains of) something, he or she describes symptoms that are
painful or uncomfortable.

5. (Short of Breath) is a condition in which a patient finds it more difficult to breathe


than usual : SOB

6. An intravenous injection is a method of administering medicine into a vein using a


syringe, often over a long period of time : I.V

7. a unit of liquid volume equal to the amount of liquid which comes from a dropper,
or about 1/12th of a milliliter : drop (gtt)

8. 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 : XR

9. a unit of volume equal to a cube whose sides are equal to one centimeter : cubic
centimeter (cc)

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

11. To give medicine to a patient : administer

12. If something is found o/e (on examination), it was discovered during an exam.

13. (subcutaneous) A medicine that is injected into the fatty layer under the skin with a
syringe ; SQ

14. (sublingual) Medicine that is given beneath the tongue : SL

15. the correct amount and frequency of medicine to give to a person : dosage

16. (intramuscular injection) A medicine that is injected into a muscle with a syringe :
IM

17. A unit of mass equal to one thousandth of a gram : milligram (mg)

18. (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 : T

19. Medicine is applied to a certain part of the surface of the body : topical

20. a unit of mass which is equal to one-thousandth of a kilogram : gram (g)


21. The path by which a medicine is taken into the body : route of administration

22. 1/1000th the weight of the minor component of a chemical solution dissolved in
the major component : milliequivalent (mEq)

23. (Diagnosis) is the positive identification of a patient's disease or ailment : Dx

24. If a medicine is given P.R (per rectum), it is taken through the rectum.

25. If medicine is given P.0 (by mouth), it is taken orally, or through the mouth.

26. (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 : BP

27. A measure of volume equal to the amount a standard tablespoon can hold or about
three teaspoons: tablespoonful (Tbsp)

28. (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 : HR

29. Drops of liquid administered to the eye : gtt

30. (hypertension) is having blood pressure that is higher than normal : HTN

31. 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

32. BP 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

33. If a patient c/o something, he or she describes symptoms that are painful or
uncomfortable

34. Dx is the positive identification of a patient’s disease or ailment.

35. HR is the frequency with which a person's heart beats in a given amount of time. It
is usually expressed in beats per minute.

36. HTN is having blood pressure that is higher than normal.

37. If something is found o/e, it was discovered during an exam.

38. Rx is the specific drug or course of action prescribed to treat a patient’s medical
condition.

39. SOB is a condition in which a patient finds it more difficult to breath than usual.

40. T is a quantitative measurement of heat within the body. It is can be used, in part,
to gauge whether the body is operating normally.
41. If a function is WNL , it is operating in a normal range.

42. XR 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.

43. to describe uncomfortable symptoms : c/o

44. the amount of internal body heat measured : T

45. Dx : "the identification of an illness or disease"

46. the amount of force applied on blood vessel walls by circulating blood : BP

47. the number of heartbeats in a given amount of time : HR

48. to be at an average level : WNL

49. discovered while investigating a patient’s health : o/e

50. The XR clearly showed that bone was broken.

51. The asthmatic patient complained of SOB

52. Rx for the infection included antibiotics

53. The patient with high blood pressure was diagnosed with HTN

54. A cc is a unit of volume equal to a cube whose sides are equal to one centimeter

55. A gtt is a unit of liquid volume equal to the amount of liquid which comes from a
dropper, or about 1/12th of a milliliter.

56. A g is a unit of mass which is equal to one-thousandth of a kilogram

57. gtt (s) are drops of liquid administered to the eye.

58. A mcg is a unit of mass equal to one millionth of a gram.

59. A mEq is 1/1000th the weight of the minor component of a chemical solution
dissolved in the major component

60. A mg is a unit of mass equal to one thousandth of a gram.

61. A ml is a unit of liquid volume equal to one thousandth of a liter and equal to one
cubic centimeter.

62. A tbsp is a measure of volume equal to the amount a standard tablespoon can hold
or about three teaspoons.

63. A tsp is a measure of volume equal to the amount a standard teaspoon can hold, or
almost five milliliters.

64. Which of the following is equal to one ml? 1 cubic centimeter


65. a unit of mass equal to one millionth of a gram : mcg

66. a unit of mass equal to one thousandth of a gram : mg

67. 1/1000th the weight of the minor component of a chemical solution dissolved in
the major component : mEq

68. a unit of mass which is equal to 1/1000th of a kilogram : g

69. a measure of volume equal to the amount a standard teaspoon can hold : tsp

70. a measure of volume equal to the amount a standard tablespoon can hold or about
three teaspoons : Tbsp

71. Please put 2 drop (s) of cleaning solution in each ear. Use a dropper.

72. Half a liter is equal to 500 ml (s)

73. One thousand g (s) make up one kilogram

74. To administer medicine is to give it to a patient.

75. A(n) dosage is the correct amount and frequency of medicine to give to a person.

76. A(n) IV is a method of administering medicine into a vein using a syringe, often
over a long period of time.

77. A(n) IM injection is a medicine that is injected into a muscle with a syringe.

78. If medicine is given P.O., it is taken orally, or through the mouth.

79. If a medicine is given P.R, it is taken through the rectum.

80. A route of administration is the path by which a medicine is taken into the body.

81. If a medicine is SQ, it is injected into the fatty layer under the skin with a syringe.

82. If a medicine is taken SL, it is given beneath the tongue

83. If a medicine is topical, it is applied to a certain part of the surface of the body.

84. injected into the fatty layer under the skin with a syringe : subcutaneous

85. taken orally, or through the mouth : P.O

86. given beneath the tongue : sublingual

87. taken through the rectum : P.R

88. injection into a vein using a syringe, often over a long period of time : IV

89. applied to a certain part of the surface of the body : topical

90. Is the route of administration for this medicine sublingual or P.O.?


91. Please get me a syringe so I can give this intramuscular injection

92. How should we administer Mr. Smith’s medicine?

93. For this patient, the correct dosage is 200 milligrams per day.

Tuần 2

94. If someone has a runny something, he or she has experienced it regularly or


repeatedly.

95. A(n) muscle ache is a pain felt in the muscles.

96. A(n) past medical history (PMH) is a patient's record of previous illnesses,
procedures, and other medical details.

97. Medication that is given at bedtime : qhs

98. To wheeze is to breathe with difficulty in a noisy manner.

99. Medication that is given immediately stat

100. If something is runny, it has liquid flowing or leaking out of it.

101. A(n) headache is a pain felt in the head.

102. Medication that is given every hour : qh

103. Medication that is given four times per day : QID

104. A(n) social history is a patient's record of lifestyle and personal details, such as
occupation and marital status.

105. Medication that is given every other day QOD

106. A(n) fever is an illness that causes body temperature to rise,

107. A(n) allergy is a medical condition that causes a reaction or illness when someone
comes in contact with a particular substance.

108. If a medication that is given twice per day : BID

109. If something is current, it is happening at the present time

110. To throb is to have pain that comes and goes very quickly.

111. To cough is to force air loudly through the throat because of an illness or throat
irritation.

112. A(n) symptom is a feeling or physical change that indicates illness.

113. A(n) family medical history is a record of the medical conditions of a patient's
family that might affect the patient's health.
114. A(n) procedure is a medical treatment performed by a doctor or surgeon.

115. A(n) cold is an illness that can cause coughing, a runny nose, and a sore throat.

116. A medication that is taken before meals ac

117. A(n) complaint is pain or illness reported by a patient.

118. A(n) onset is the start or first instance of something.

119. Medication that is given as needed : PRN

120. data is a collection of information.

121. Medication that is given three times per day : TID

122. flu is a viral illness that can cause fevers, aches, and wheezing,

123. Medication that is given after meals : pc

124. QH means given every hour

125. If something is current, it is happening at the present time

126. An illness that causes discomfort in the head and body : cold

127. Fatigue is a symptom _ of the flu

128. the first instance of something : onset

129. The patient's past medical history included her previous surgeries

130. A(n) social history is a patient’s record of lifestyle and personal details, such as
occupation and marital status.

131. If a medication is given TID, it is given three times per day.

132. A symptom is a feeling or physical change that indicates illness.

133. A cold is an illness that can cause coughing, a runny nose, and a sore throat.

134. If a medication is given stat, it is given immediately.

135. If a medication is given pc, it is given after meals.

136. According to the thermometer, the patient has a fever

137. If something is runny, it has liquid flowing or leaking out of it.

138. The pain in my back throbs

139. TID means given three times per day


140. To cough is to force air loudly through the throat because of an illness or throat
irritation.

141. a pain or illness reported by a patient : complaint

142. If a medication is given ac , it is before meals.

143. flu is a viral illness that can cause fevers, aches, and wheezing,

144. The patient should take this medication before he eats. The underlined part has the
same meaning as: ac

145. To throb is to have pain that comes and goes very quickly.

146. a medical treatment : procedure

147. A(n) complaint is pain or illness reported by a patient.

148. If a medication is given qh, it is given every hour,

149. QID means: given four times per day

150. If a medication is given BID , it is given twice per day.

151. You should take this antibiotic when you go to bed. The underlined part has the
same meaning as: qhs

152. PRN means: qhs

153. The patient's current condition was caused by a recent injury.

154. A fever is an illness that causes body temperature to rise,

155. If a medication is given QID , it is given four times per day.

156. To wheeze is to breathe with difficulty in a noisy manner.

157. A(n) procedure is a medical treatment performed by a doctor or surgeon.

158. I need 50 cc's of lidocaine immediately! The underlined part has the same meaning
as: stat

159. If a medication is given QOD , it is given every other day.

160. The patient's social history included her occupation.

161. a record of a patient’s family’s conditions : family medical history

162. Medical professionals take medical histories to uncover information that might
help with diagnoses.

163. to breathe noisily and with difficulty : wheeze

164. If a medication is given qhs, it is given at bedtime.


165. data is a collection of information.

166. If a medication is given PRN, it is given as needed.

167. Paul's family has a history of cancer.

168. A(n) family medical history is a record of the medical conditions of a patient’s
family that might affect the patient’s health.

169. If someone has a history of something, he or she has experienced it regularly or


repeatedly.

170. Take two of these after you eat. The underlined part has the same meaning as: pc

171. Helen was coughing because of the flu

172. having liquid leaking from something: runny

173. A(n) allergy is a medical condition that causes a reaction or illness when someone
comes in contact with a particular substance.

174. to force air loudly through the throat : cough

175. A(n) past medical history is a patient’s record of previous illnesses, procedures,
and other medical details.

176. You will need to take a pill once every hour until you start to feel better : qh

Tuần 3

177. A(n) ultrasound is a medical imaging technique that uses the reflection of sound
waves to produce an image of the body.

178. A(n) biopsy is a medical procedure in which a piece of tissue is removed and
examined to help determine an illness.

179. If something is renal, it is related to the kidneys.

180. blood pressure is a measure of the pressure with which blood moves through the
body.

181. medical imaging is the process of creating pictures of the human body for the
purpose of diagnosing and treating medical problems.

182. A(n) endoscope is a thin, tubular instrument used to examine the inside of an organ
or body cavity.

183. To affect something such as mood is to bring about a change in it.

184. A(n) pulse 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.
185. radiography is the use of x-rays to view images of the internal human body.

186. creatinine is a waste product found in blood that the kidney usually removes.

187. To evaluate something is to determine the qualities of its condition or state.

188. body language is the conveyance of information about a person's physiological or


emotional state by the way he or she moves.

189. To feed an endoscopic tube is to insert it into the body in order to take internal
pictures,

190. A(n) inspection is an organized examination of a patient's physiological state as


compared to what is understood to be normal.

191. auscultation is the examination of something by listening with or without an


instrument such as a stethoscope.

192. palpation is the examination of something by touch.

193. A(n) observation is something that someone notices, or the act of noticing
something.

194. albumin is a type of protein found in the body.

195. vital signs are statistical measures of essential body functions such as temperature,
pulse rate, blood pressure, and respiration.

196. A(n) pathology report is a report that discusses what was found after cells and
tissue were examined.

197. A(n) magnetic resonance imaging (MRI) is a medical imaging technique that uses
magnetic forces on atoms to produce an image of the body.

198. A(n) x-ray is a form of radiation that can be used to take pictures of the internal
human body

199. A glomerular filtration rate test (GFR) test is a test to determine how much kidney
function a person has.

200. chronic kidney disease (CKD) is a medical condition in which a person loses kidney
function over time.

201. A(n) urinalysis is a test that examines a urine sample.

202. A blood urea nitrogen test (BUN) test is a test to determine the amount of urea
nitrogen in the blood.

203. gel is a semi-solid substance placed between the patient's skin and an ultrasound
probe.

204. A(n) electrocardiogram (ECG)is a measurement of the electrical activity of the


heart over a period of time.
205. 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.

206. A(n) CT scan is a form of medical imaging that uses many two-dimensional X-rays
to create a three-dimensional image of an object.

207. A(n) pulse 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

208. palpation is the examination of something by touch

209. A(n) urinalysis is a test that examines a urine sample.

210. a waste product found in blood that the kidney usually removes : creatinine

211. Get a(n) ECG of that patient’s heart activity.

212. Which of the following is not an aspect of checking vital signs? evaluating posture
(evaluating patient's mood / observation of the patient's body language)

213. A blood urea nitrogen (BUN) test is a test to determine the amount of urea nitrogen
in the blood.

214. something is renal, it is related to the kidneys.

215. The nurse forgot to determine the quality of the patient’s posture : evaluate

216. A(n) observation is something that someone notices, or the act of noticing
something

217. A(n) electrocardiogram (ECG)is a measurement of the electrical activity of the


heart over a period of time.

218. a medical imaging technique that uses the reflection of sound waves to produce an
image of the body". ultrasound

219. a type of protein found in the body : albumin

220. To evaluate something is to determine the qualities of its condition or state.

221. Which of the following is an advanced medical imaging technique? CT scan.


(ECG / MRI / CT scan)

222. Which of the following is an aspect of checking vital signs? auscultation

223. The doctor performed an investigation of the patient’s ear. inspection

224. A(n) CT scan is a form of medical imaging that uses many two-dimensional X-rays
to create a three-dimensional image of an object.

225. People can have a relatively normal life with just one kidney.
226. a thin, tubular instrument used to examine the inside of an organ or body cavity :
endoscope

227. A(n) endoscope is an organized examination of a patient’s physiological state as


compared to what is understood to be normal.

228. a test that examines a urine sample : GFR test - Glomerular filtration rate / BUN
test Blood Urea Nitrogen

229. body language is the conveyance of information about a person’s physiological or


emotional state by the way he or she moves.

230. Which of the following is NOT an advanced medical imaging technique? X-ray

231. The bone is likely broken, but take a(n) X-ray to make sure.

232. The doctor will feed a tube into the man’s chest to see pictures with the endoscope.

233. We will remove some tissue from your liver during the biopsy.

234. The patient’s back pain seemed to make a difference upon her mood : affect

235. Which of the following is a physical examination technique? Auscultation

Physical examination techniques: - auscultation


- palpitation
- percussion

236. Which of the following is an advanced medical imaging technique? ECG

237. Apply this gel to the area before using the ultrasound machine.

238. To affect something such as mood is to bring about a change in it.

239. Your blood pressure reading, at 110/65, is on the low end of the normal range.

240. The use of X-rays to view images of the internal human body : radiography

241. a medical condition in which a person loses kidney function over time". chronic
kidney disease

242. gel is a semi-solid substance placed between the patient’s skin and an ultrasound
probe.

243. The pathology report will show the results from several tests.

244. A(n) endoscope is a thin, tubular instrument used to examine the inside of an organ
or body cavity.

245. A(n) pathology report is a report that discusses what was found after cells and
tissue were examined.
246. a test to determine the amount of urea nitrogen in the blood : BUN test

247. vital signs are statistical measures of essential body functions such as temperature,
pulse rate, blood pressure, and respiration.

248. Which of the following is an aspect of checking vital signs? checking pulse

249. radiography is the use of x-rays to view images of the internal human body.

250. CT scan is a form of medical imaging that uses many two-dimensional X-rays to
create a three-dimensional image of an object"

251. A(n) magnetic resonance imaging (MRI) is a medical imaging technique that uses
magnetic forces on atoms to produce an image of the body.

252. creatinine is a waste product found in blood that the kidney usually removes.

253. Which of the following is an advanced medical imaging technique? MRI

254. Through watching carefully the doctor noticed that the patient was limping :
observation

255. A GFR test tests how well kidneys are working.

256. a yellow liquid waste product that the body produces : urine

257. A(n) biopsy is a medical procedure in which a piece of tissue is removed and
examined to help determine an illness :

258. What is one use for percussion techniques? to check the condition of internal
organs

259. a medical imaging technique that uses magnetic forces on atoms to produce an
image of the body". MRI

260. 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.

261. Who is most likely to be examined by an ultrasound? a patient who is pregnant

262. Which of the following is an aspect of checking vital signs? taking temperature

263. A(n) ultrasound is a medical imaging technique that uses the reflection of sound
waves to produce an image of the body

264. A glomerular filtration rate (GFR) test is a test to determine how much kidney
function a person has.

265. A(n) x-ray is a form of radiation that can be used to take pictures of the internal
human body

266. auscultation is the examination of something by listening with or without an


instrument such as a stethoscope.
267. If one or both kidneys decline in function you may have renal failure.

268. chronic kidney disease (CKD) is a medical condition in which a person loses kidney
function over time.

269. blood pressure is a measure of the pressure with which blood moves through the
body.

tuần 4

270. packaging is a material used to wrap or protect good that are sold in stores

271. In Russia, we prefer to buy over-the-counter products, like cold remedies or cough
syrup, from people in pharmacies wearing white lab coats

272. By the end of the meeting I hope we will have come up with deliverables for getting
the project off the ground and a full to do list.

273. Laboratory technician operates complex scientific instruments and performs tests
to determine whether ingredients in liquids, powders, or tablets meet
requirements.

274. In Russia, we prefer to buy over-the-counter products, like cold remedy or cough
syrup, from people in pharmacies wearing white lab coats.

275. Preclinical data is the information about a medication that is assessed before
clinical trials.

276. With your input, I'll be able to finalize the timelines for planning and
implementation and decide on milestone (s) before our next meeting.

277. Prescription drug is the medicine bought in a pharmacy and requiring a written
note from the doctor.

278. Feasibility study is an investigation to determine the advantages, practicality, and


profitability of a proposed project

279. With your input, I'll be able to finalize the timelines for planning and
implementation and decide on milestones before our next meeting.

280. I operate complex scientific instruments and perform tests to determine whether
ingredients in liquids, powders, or tablets meet requirements.

281. Feasibility study is an investigation to determine the advantages, practicality, and


profitability of a proposed project.

282. It's the Medical writer job to research, write, and edit clinical and study reports
before the pharmaceutical company submits them to regulatory authorities.

283. In Europe, the strength of medicine varies considerably depending on what health
authorities allow.
284. I collect drug safety information about patients on our medication (s).

285. I am the clinical trial manager assigned to this project and am supported by two
clinical research associates who will work with test centres in northern Italy and in
Slovenia

286. When people liaise with another, they work together and keep each other
informed about what is happening.

287. Unlike in many countries, you'll also find many cheerful bright coloured ads in
magazines, which promote anti-depressants and other prescription drugs in the
US.

288. Self-medicate means to take medicine without consulting a physician.

289. Charley is to describe the technical equipment needed with a cost estimate by the
end of the month.

290. 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.

291. Colleague is someone you work with; a co-worker

292. powder a dry substance in the form of very small grains.

293. In France, medicines should not only cure a disease, but also look fresh and
interesting.

294. A Formulation scientist develops pharmaceutical dosage forms.

295. consultant is someone whose job is to give advice on a particular subject.

296. A Subsidiary is a company which is part of a larger and more important company.

297. 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.

298. I operate complex scientific instruments and perform tests to determine whether
ingredients in liquids, powders, or tablets meet requirements.

299. Feasibility study is an investigation to determine the advantages, practicality, and


profitability of a proposed project.

300. Since the conclusion of our successful feasibility study, we have also obtained very
encouraging preclinical data.

301. Project members from Marketing, Production, and Clinical Affairs are already on
board
302. I would like you to introduce yourselves and say something about your
professional background, area of expertise

303. Analgesic is a medication to reduce or eliminate pain.

304. B.S stands for bachelor's degree.

305. Ingredient is a substance in a drug.

306. We plan to launch our new drug in Europe first and to apply for Food and Drug
Administration (FDA) approval in the US the following year.

307. CRO is searching for omeone to co-ordinate and perform analytical testing for
stability studies of new products.

308. We will need to fill the position of clinical trial manager shortly. I'd appreciate it if
you could write up a job advertisement with the input below and place it in the
pharmaceutical journal we normally use.

309. Pharmaceutical companies must report serious adverse events to the health
authority

310. Pharmaceutical products in the pipeline are future drugs, not yet on the market.

311. I was involved in the initial conceptual design phase, the planning and building of
our new pharmaceutical facility in Shanghai, and now I am the plant manager.

312. We test or organize testing on live subjects and make sure that our drugs are safe
and effective for the patients.

313. Cross-cultural means involving two or more different cultures.

314. 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.

315. Clinical research associate performs clinical trials. Clinical research associate must
also summarize, interpret and process clinical data.

316. MSc stands for master of science degree.

317. We plan to launch all of these products in Europe first and to apply for food and
drug administration (FDA) approval in the US the following year.

318. 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.

319. Formulation scientists develop pharmaceutical dosage forms.

320. According to European law, a qualified person is responsible for the quality of each
product that leaves the production line
321. Production department compounds the raw materials into drugs, packages them,
and puts in the leaflets for the patients.

322. Pharmaceutical companies must report serious adverse events to the health
authorities.

323. You need to be able to write scientifically and technically accurate protocols in
English.

324. A project manager co-ordinates and manages the cross-functional teams that
develop and launch a new product

325. As far as Marketing is concerned, Carole Marks will be flying in from France. She'll
give us more information on the marketing claim (s) and a target patient profile.

326. Feasibility study is an investigation to determine the advantages, practicality, and


profitability of a proposed project.

327. A(n) memo is a short official note that is sent by one person to another within the
same company or organization.

328. Unlike in many countries , you'll also find many cheerful, bright coloured ads in
magazines, which promote anti-depressant and other prescription drugs in the US.

329. The marketing department plans the promotion and distribution of drugs which
will be launched, and make decisions about the packaging or tablet colour of new
products

330. 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
imperfection in one single package, even if it makes no difference to the product at
all.

331. BSc stands for bachelor of science degree.

332. A Pharmacovigilance manager collects drug safety information after approval and
reports any serious adverse events to the health authorities.

333. 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 custom (s) and
laws.

334. Feasibility study is an investigation to determine the advantages, practicality, and


profitability of a proposed project.

335. Clinical Affairs department tests or organizes testing on live subjects, and makes
sure that the drugs are safe and effective for the patients.

336. Formulation scientists develop pharmaceutical dosage forms.

337. I did research on clinical methodology


338. deadline a date or time by which you have to do or complete something.

339. MS stands for master's degree.

340. A Project manager co-ordinates and manages the cross-functional teams that
develop and launch a drug.

341. Since the conclusion of our successful feasibility study, we have also obtained very
encouraging preclinical data (= end)

342. Quality Assurance (QA) department ensures that products meet the standards
which the law requires, and contain the active ingredients advertised.

343. A Qualified person is personally responsible for the quality of each product that
leaves the production line. A Qualified person must manage all the processes in
production, QA, and the labs to make sure SOPs are followed.

344. Before they become fully qualified, pharmacists in the US have to take an
examination to get a licence to practise pharmacy.

345. 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

346. I received my master's degree at New York University and licence to practise
pharmacy in the United States

347. A clinical trial manager 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.

348. Health regulations are rules or laws about health.

349. We compile the drug documentation and send it to the regulatory drug authority so
we can get authorization to market the product.

Tuần 5

350. Medicine needs to be easily accessible. This is, of course, a question of public
health. On the other hand, these same products can do harm if used incorrectly.
This danger must be avoided.

351. Scientists have made a major breakthrough in the treatment of cancer.

352. When someone has palpitations, their heart beats very fast in an irregular way.
(conditions of heart racing )

353. Formulation is a mixture of ingredients prepared in a certain way and used for a
specific purpose.

354. Diabetes refers to a group of diseases that affect how your body uses blood sugar
(glucose).
355. The science of poisons, including their source, chemical composition, action, tests ,
and even their antidote (s) , is what we call Toxicology

356. Medication must meet four criteria in order to obtain the status of a non-
prescription or OTC. It must have: a large margin of safety , low incidence of side
effects, low potential for misue and abuse, and labelling that provides adequate
directions for sale and effective use.

357. When substances are taken with alcohol or antibiotics, their chemical form could
change and even cause harmful side effects.

358. Solution is a liquid in which another substance has been dissolve (d)

359. Research is the process of testing chemical compounds, with the goal of finding a
substance which has a beneficial effect on a targeted disease.

360. Nausea is the condition of feeling sick and the feeling that you are going to vomit.

361. Suppository is a solid medicine which melts slowly in the rectum or vagina.

362. 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.

363. When you chew food, you use your teeth to break it up in your mouth so that it
becomes easier to swallow.

364. Lotions are fluid preparations (aqueous) for external application without friction.

365. Clinical trial is a scientific study designed to systematically test a medical


intervention in humans.

366. New chemical entity is a unique, pharmacologically active product that has never
previously been synthesized or used to treat disease.

367. Ointments are semi-solid, smooth greasy preparations for application to the skin
for healing.

368. If you have Indigestion, you have pains in your stomach and chest that are caused
by difficulties in digesting food.

369. Dosage is the amount and frequency of a medicinal drug that may be taken safely.

370. One of criteria to obtain the status of OTC product in the US is that a medication
must have low incidence of side effects.

371. In the fields of medicine, biotechnology and pharmacology, drug discovery is the
process by which new candidate medications are discovered.

372. anaemia is a medical condition in which there are too few red cells in your blood,
causing you to feel tired and look pale.
373. First in-man study is Phase-1 study in which a test product is administered to
human beings.

374. Some medications are available in liquid form, such drops or syrup.

375. Pharmaceutical product labelling must provide adequate directions for sale and
effective use.

376. Dosage form is the final form of the medicine, e.g. Tablet, powder, gel, spray, etc.

377. Toxicity is the degree to which a substance (a toxin or poison) can harm humans or
animals.

378. Pneumonia is the inflammation of the lungs. The lungs become filled with liquid
which makes it difficult to breathe.

379. Allergic reaction is the body's exaggerated immune response to an internal or


surface agent.

380. Oral solution is a liquid in which another substance has been dissolved.

381. Toxicology is the study of poisons.

382. Pill is a small, round piece of medicine to be swallowed without chewing.

383. An Inhaler is a small device with medicine to breathe in through the mouth.

384. Suppository is a solid medicine which melts slowly in the rectum or vagina.

385. A specialist or expert in the scientific field of chemistry is called a chemist.

386. Which of the following dosage form(s) do the patients favour (= prefer)?

387. Mensamint is a new dosage form of Mensadent. Known side effects often include
loss of sleep if taken in the late afternoon or evening. occasionally (now and then ),
an increase in blood pressure may occur.

388. Dose is the amount of substance given at one time.

389. Toxicology is the study of poison.

390. If a wound or a part of your body becomes septic , it becomes infected.

391. Nasal spray is a substance dispensed as a fine spray from a container into the
nostril.

392. 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.

393. If you have a fever when you are ill, your body temperature is higher than usual.
394. Someone who suffers from insomnia finds it difficult to sleep.

395. Syrup is a sweet, liquid medicine taken with a spoon or cup.

396. Research is the process of testing chemical compounds, with the goal of finding a
substance which has a beneficial effect on a targeted disease.

397. An Ailment is an illness, especially one that is not very serious.

398. Pharmacology is the study of drugs, how they work, and what they do in the body.
Pharmacology can be divided into two separate areas: Pharmacodynamics and
Pharmacokinetics.

399. Asthma is a lung condition which causes difficulty in breathing.

400. 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 misuse and abuse, and -
labelling that provides adequate directions for sale and effective use.

401. Eye drops are a kind of medicine that you put in your eyes one drop at a time.

402. Suppository is a solid medicine which melt (s) slowly in the rectum or vagina.

403. Pharmacodynamics is the study of physiological effects of drugs and the


mechanisms of their actions (what the drug does to the body)

404. Sublingual tablet is administered by placing it under the tongue.

405. Lozenge is a solid preparation that is intended to dissolve or disintegrate slowly in


the mouth (e.g.. Sore throat)

406. 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.

407. Chewable tablet is chewed prior to swallowing. It is designed for administration to


children e.g. vitamin products.

408. Topical dosage forms are applied to the skin surface.

409. A Chronic illness or disability lasts for a very long time. Opposite to acute.

410. Mensamint is a new dosage form of Mensadent. Known side effects often include
loss of sleep if taken in the late afternoon or evening. Occasionally, an increase in
blood pressure may occur.

411. Diarrhoea is a condition in which faeces are discharged from the bowels frequently
and in a liquid form.

412. 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.
413. Over-the-counter drug is a product which can be sold without the patient seeing a
doctor.

414. Effervescent tablet is an uncoated tablet containing substances that react in the
presence of water and give off carbon dioxide.

415. Patch is a medication on material or cloth placed on the skin.

416. Toxicologist is an expert in the science of poisons.

417. Drug development is the process of carry forward scientific discoveries made
during the research process, with the goal of producing a marketable drug.

418. Development is the process of carrying forward scientific discoveries made during
the research process, with the goal of producing a marketable drug

419. 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.

420. Pharmacokinetics is the study of the bodily absorption, distribution, metabolism,


and excretion of drugs (what the body does to the drug)

421. Route of administration is the path by which a drug, fluid, poison, or other
substance is taken into the body.

422. Gel is a drug delivery system consisting of a semi-solid, jelly-like substance.

423. An inhaler is an aerosol dispensing device which releases medication into the
mouth of the patient.

424. Behind-the-counter medicine can be purchased without a prescription but only


with the personal involvement of a pharmacist.

425. Tablet is a hard, compressed medication in round, oval or square shape

426. We will have to test the bioavailability to be able to calculate dosages for non-
intravenous routes of drug administration for this NCE.

427. Mensamint is a new dosage form of Mensadent ( Obtainable with plysician's


prescription only)

428. Chemists and pharmacologist (s) are also interested in how the medicine is
administered, so they often ask about its formulation.

429. aerosol is a container with a liquid that is administered in spray form.

430. Bronchitis is the inflammation of the bronchial tubes, characterized by coughing,


difficulty in breathing.

431. Patches are easy to apply, not too expensive, and can be placed right at the point of
pain.
432. Toxicology is the science of poisons, including their source, chemical composition,
action, tests and their antidotes.

433. One of criteria to obtain the status of OTC product in the US is that a medication
must have low potential for misuse and abuse.

434. OTC Pharmaceutical products must have labelling that provides adequate
directions for sale and effective use.

435. Liniment is an oily liquid to rub on painful body parts to reduce pain.

436. At present, the Food and Drug Administration is reviewing its current policy on the
number of categories of medicines.

437. In Canada, Behind-the-counter medicines are those that a patient can obtain
without a prescription, but only with the personal involvement of a pharmacist.

438. Inhaled dosage forms are breathed in through mouth or nose and are often used to
treat respiratory diseases.

439. Time-release delivery means a drug preparation that gradually releases an active
substance over a period of time.

Tuần 6

440. GCP stands for Good Clinical Practice.

441. All operational procedures and methods must also be inspected for accuracy.

442. Contaminated products are no longer pure and acceptable for sale or public use
and, therefore, must be returned to the manufacturer or destroyed.

443. improper disposal of toxic waste material was recorded. (= incorrect/ wrong)

444. The reason for interim testing, or Product sampling, is to check the quality of
pharmaceutical products.

445. Protective glasses/ goggles must be worn at all times in the laboratory.

446. 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 follow-up review in 30 days

447. Proper protective clothing and safety equipment must be worn at all times

448. Endpoint testing is carried out at the end of every manufacturing process. This is to
ensure that all procedures have been performed in compliance with industry and
company standards.

449. documentation is important and necessary at every step of the processes, activities,
and operations involved in drug manufacturing.

450. A/An auditor inspects and verifies the safety procedures in the lab.
451. This memo is to advise you that your department has been scheduled for a periodic
audit of the laboratory safety systems and procedures.

452. 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 maintain
performance and results

453. CAPA focuses on the systematic investigation of non-conformance events (errors


or deviations), to prevent their occurrence (for preventive action) or recurrence
(for corrective action).

454. Documentation is important and necessary at every step of the processes,


activities, and operations involved in drug manufacturing.

455. I suggest you dispose of toxic waste in the bins provided for this purpose.

456. Please confirm receipt of this memo and send us a copy of all your correspondence
with regard to this scheduled audit.

457. 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 cause of the contamination.

458. At the end of every stage of a product's manufacturing process, Endpoint testing is
done to maintain quality standards.

459. Endpoint testing is carried out at the end of every manufacturing process to ensure
that all procedures have been performed in compliance with industry and company
standards.

460. Any observation or finding noted by the auditors is categorize (d) as either major,
minor, or critical.

461. Quality control involves interim and product sampling procedures, which are
carried out to check product quality.

462. If any non-compliance is observed during the audit, the department will be
informed so they can take corrective action.

463. 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 complaint within a short period of time.

464. Corrective Action/Preventive Action (CAPA) is a part of the overall Quality


Management System (QMS) required for GMP. It focus (es) on the systematic
investigation of non-conformance events (errors or deviations), to prevent their
occurrence (for preventive action) or recurrence (for corrective action).

465. Even a product that has been marketed for years might have to be taken off the
market in a Product recall if serious adverse reactions occur.

466. GDP stands for Good Documentation Practice


467. proper documentation not only enables traceability, but also allows a complete
product recall from the market, if necessary.

468. To ensure that laboratory workers are asked certain questions about safety
procedures, auditors use a Checklist

469. Corrective action / Preventive action ( CAPA ) is a part of the overall Quality
Management System ( QMS) required for GMP .

470. Aspirin mainly used for pain relief and fever.

471. 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.

472. Proper protective clothing and safety equipment must be worn at all times.

473. A few years ago, a well-known European pharmaceutical company was forced to
recall one of its drugs due to claim s of product contamination.

474. Validation of cleaning processes is essential in this industry, because chemical or


bacterial contamination of drug products can potentially lead to severe public
health risks.

475. A(n) annual audit of safety procedures in all laboratories is carried out yearly.

476. Corrective action prevents recurrence of errors

477. 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 maintain
performance and results

478. Disinfectant must be used on all equipment following an experiment with


laboratory animals.

479. Even a product that has been marketed for years might have to be taken off the
market if serious adverse drug reaction (s) occur.

480. Special containers are provided for the disposal of toxic waste materials.

481. An internal audit involes inspection and validation of operational methods,


procedures, equipment to ensure functionality, accruacy and validity

482. Any observation or Finding noted by the auditors is categorized as either major,
minor, or critical.

483. Beyond the filed of manufacturing, good practice must be adhere (ed) to in all
processes in a pharmaceutical company

484. The goal of an internal audit is to identify any areas requiring corrective or
preventive actions. It is done to assure compliance with industry standards,
especially for safety procedures.
485. The quality assurance process in good manufacturing practice (GMP) includes
product quality control, sampling, and testing.

486. It is absolutely essential to move lab mice outdoors in closed cage (s) .

487. Special container (s) are provided for the disposal of toxic waste materials.

488. Preventive action prevents occurrence of errors.

489. Manufacturing processes and procedures must go through periodic Validation to


guarantee that they are still of an acceptable standard.

490. disinfectant must be used on all equipment following any experiments with
laboratory animals.

491. Inspection and validation are required to prove that the manufacturing and testing
equipment is functional.

492. An Odour is a distinctive unpleasant smell.

493. All operational methods and procedures must also be inspected for accuracy.

494. A well-known European pharmaceutical company was force (ed) to recall one of its
drugs due to claims of product contamination.

495. GAP stands for Good Auditing Practice.

496. Proper documentation not only to enable (s) traceability, but also allows a
complete product recall from the market.

497. A/an fire blanket is a safety device consists of a sheet of a fire retardant material
which is placed over a fire in order to extinguish it.

498. The reason for interim testing, or product sampling, is to check the quality of
pharmaceutical products

499. The documentation required for all research processes and development steps
ensures the Traceability of a drug.

500. Auditors generally watch or observe safety procedures in the lab.

501. Lab animals must be transported in covered cages.

502. Endpoint testing is carried out at the end of every manufacturing process. This is to
ensure that all procedures have been performed in compliance with industry and
company standards.

503. All laboratory work must be documented in accordance with GLP.

504. Preventive action prevents occurrence of errors

505. Quality assurance involves all manufacturing processes in GMP which make sure
the goods produced are kept at high standards.
506. GLP stands for Good Laboratory Practice.

507. CAPA stands for Corrective Action/Preventive Action. It is a part of the overall
Quality Management System (QMS) required for GMP

508. All work with virus- infected animals must be performed in the bio-safety cabinet.

509. Small biological agent spills must be covered with a paper towel and treated with
bleach .

510. GSP stands for Good Safety Practice

511. Safety procedures make sure that the health and well-being of laboratory workers
are guaranteed.

512. advance notice of this meeting was very short.

513. Small biological agent spills must be covered with a paper towel and treated with
bleach .

514. A Holistic approach looks at all aspects of a pharmaceutical company together to


make sure that the entire process meets high industry standards.

515. A few years ago, a well-known European pharmaceutical company was forced to
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 global figure at over 40,000 people.

516. A/an Gas mask is a device that you wear over your face in order to protect yourself
from poisonous gases.

517. 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.

518. An internal Audit involves inspection and validation of operational methods,


procedures, equipment to ensure functionality, accuracy and validity.

519. GMP stands for Good Manufacturing Practice.

520. The company claims that a cleaning error was the reason for the entire incident.
This clearly underlines the danger of underestimating the importance of the
cleaning process in pharmaceutical manufacturing.

521. Toxic or hazardous materials must be disposed of properly.

522. Scientists often read journals and go to international conferences, because they
need to stay up-to-date in their scientific fields.

523. You need to disinfect all equipment following any experiments with laboratory
animals.
524. Contaminated products are no longer pure and acceptable for sale or public use
and, therefore, must be returned to the manufacturer, or destroyed.

525. A few years ago, a well-known European pharmaceutical company was forced to
recall one of its drugs due to claims of product contamination

526. Contaminated drugs are no longer pure and acceptable for sale or public use and,
therefore, must be returned to the manufacturer, or destroyed.

527. inspection and validation are required to prove that the manufacturing and testing
equipment is functional

528. Please confirm receipt of this memo and send us a copy of all your correspondence
with regard to this scheduled audit.

529. Documentation is important and necessary at every step of the processes,


activities, and operation (s) involved in drug manufacturing.

530. We should tell the lab staff to double-check that all the labs are spotlessly clean and
that all lab devices and equipment are where they should be - at every single
workstation.

531. Quality Management System (QMS) is a formalized system that documents


processes, procedures, and responsibilities for achieving quality policies and
objectives.

532. A well-known European pharmaceutical company was forced to recall one of its
drugs due to claims of product contamination.

533. Corrective Action/Preventive Action (CAPA) focuses on the systematic


investigation of non-conformance events (errors or deviation (s)), to prevent their
occurrence (for preventive action) or recurrence (for corrective action).

534. Overshoes are shoe covers used to reduce foot borne contamination and help
maintain a sterile environment.

535. Eye bath is a/an apparatus to wash the eyes after exposure to chemical
contamination.

536. The quality assurance process in good manufacturing practice (GMP) includes
product quality control, sampling, and testing.

537. Endpoint testing is carried out at the end of every manufacturing process. This is to
ensure that all Procedure (s) have been performed in compliance with industry
and company standards.

538. To clarify something means to make it easier to understand, usually by explaining


it in more detail.

539. Genotoxic substance is a chemical that damages cellular DNA, resulting in


mutations or cancer.
Tuần 7

540. in vitro means "in cells in a test tube"

541. During the preclinical developmentof a drug , laboratory tests document the effect
of the investigational drug in living organism , and in cells in a test tube (in vitro).

542. Phase III Trials: 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.

543. Adverse reaction refers to all abnormal and unintended response to an


investigational medicinal product related to any dose administered.

544. cancer is a serious disease in which cells in a person's body increase rapidly in an
uncontrolled way, producing abnormal growths.

545. A drug that is intended to act on the sinuses may be formulated as a time-release
capsule, or as a nasal spray.

546. Creams are semi-solid emulsion, that is mixtures of oil and water.

547. The parents took the authority to court after their daughter had died of cancer.

548. Adverse reaction refers to all abnormal and unintended responses to an


investigational medicinal product related to any dose administered.

549. Do terminally ill patients have the legal right to try to prolong their lives by taking
experimental drugs?

550. The safety and efficacy of a drug can only be determined by conducting rigorous
clinical trials, according to the FDA.

551. In Phase III, 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.

552. In phase Phase IV , further information regarding drug's safety, efficacy, and the
ideal(optimal) use of the drug is collected.

553. In the preclinical stage of drug development, a(n) investigational drug must be
tested extensively in the laboratory. This is to ensure it will be safe to administer to
humans.

554. in vivo means "in living organisms"

555. In Phase I the drug reacts in the body, toxicity, metabolism, absorption, and
excretion are observed and documented.

556. Phase I Trials: These are studies which are performed to evaluate the safety of
drugs in healthy people, and to determine the pharmacological properties of drugs.
557. Phase IV is the post-marketing study after getting approval for general sale.

558. Phase II is the first phase in which patients with the target disease or disorder take
part.

559. Phase I Trials: These are studies which are performed to evaluate the safety of
drugs in healthy people and to determine the pharmacological properties of drugs.

560. Phase I is performed to evaluate the safety of drugs in healthy people, and to
determine the pharmacological properties of drugs

561. Clinical trials are mainly aimed at answering scientific questions. In general, their
goal is to gather statistics to determine whether an experimental drug is safe and
effective.

562. After gaining evidence that the drug is effective, these controlled and uncontrolled
trials are carried out to obtain additional information to evaluate the overall
benefit-risk relationship of the drug.

563. The parents of a 21-year-old woman challenged the FDA.They took the authority to
court after their daughter had died of cancer.

564. 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 administer to
humans.

565. CMC stands for Chemistry, Manufacturing and Controls. It is a part of new
pharmaceutical product application to the US Food and Drug Administration.

566. The dogs started retching and vomiting and were separated to allow closer
observation.

567. An adverse event is any abnormal medical occurrence in a patient or clinical trial
subject after a medicinal product has been administered .

568. Phase IV Trials: They are carried out in order to gather further information about
the drug's safety, efficacy, and optimal use.

569. Sensitive means quick to detect or respond to slight changes, or influences. e.g.
Dogs are more Sensitive to drugs than mini-pigs.

570. An adverse event is any abnormal medical occurrence in a patient or clinical trial
subject after a medicinal product has been administered.

571. Test subjects in the treatment group receive the medication under study, whereas
the control group receives either a standard medication or a placebo.

572. Phase III is the final phase before getting marketing approval.

573. Extensive documentation must be provided to the appropriate regulatory


authorities.
574. Sensible means practical and reasonable. e.g. It was a Sensible decision to cancel
the trial.

575. Regulatory agencies require testing that documents the characteristics -chemical
composition,purity quality,and potency -of thedrug's active ingredient,and of the
formulated drug.

576. A Chemistry lab technician assists chemists and chemical engineers using
chemicals and related products

577. Shortly means 'soon'. e.g. The adverse event occurred shortly after the injection.

578. Drug Excretion is the removal of a drug or its metabolites from the body.

579. Phase II clinical trial is performed after there is preliminary evidence that the drug
is effective.

580. Phase III is the final phase before getting marketing approval.

581. The products of drug metabolism are called Metabolites.

582. Briefly means 'for a short time' . e.g. The trial director spoke briefly to his staff
about the current status of the trial.

583. Miki has been invited to join an impromptu lab meeting about drug substance MPP
010098, which is being tested in dogs. ( = without planning or organizing it in
advance.)

584. The general health and behaviour of the dogs were checked twice a day.

585. Phase II Trials: These are controlled studies conducted to evaluate the
effectiveness of the drug in a particular indication and to determine possible side
effects and risks

586. Regulatory agencies have to give permission to commence with the clinical testing
in humans, which is also done at our company.

587. The general health of the dogs was regularly checked. On Day 2, abnormalities
regarding food consumption were observed shortly after administration in the
high-dosegroup.

588. In addition, the overall appearance and behaviour of each animal was assessed
twice a day

589. Effect is the result of a change. e.g. I felt the Effect of the new ointment right away.

590. An adverse event 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.
591. An Adverse event 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.

592. Many terminally ill people fall victim to the therapeutic misconception that the
objective of trials is to cure them.

593. In phase Phase II, testings are done to determine the safety and efficacy of the drug
in treating the condition and establishes the minimum and maximum effective
dose.

594. 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)

595. abnormality (s) regarding food consumption were observed shortly after
administration in the high- dose group.

596. Phase II Trials are controlled studies conducted to evaluate the effectiveness of the
drug in a particular indication and to determine possible side effects and risks.

597. 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 clinical testing in humans.

598. Drug Absorption is the movement of a drug from its site of administration into the
blood.

599. Subjects in a trial must be willing to be randomly assigned to either the group
which receives the unapproved medication or the one which gets a placebo

600. Phase III is the final phase before getting marketing approval.

601. The safety and efficacy of a drug can only be determined by conducting rigorous
clinical trials, according to the FDA.

602. Many terminally ill people fall victim to the 'therapeutic misconception that the
objective of trials is to cure them.

603. First of all, it is the intention of the company to complete the preclinical trials by
the end of the year.

604. A Disease is an abnormal condition that affects the body of an organism, often
caused by pathogens. e.g. There is a history of lung Disease in the family.

605. The active ingredient currently being tested seems to affect the kidneys.

606. 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 Illness.

607. Toxicology ís the study of the potential risks to the body.


608. A Control group 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.

609. Drug Distribution is the movement of drugs throughout the body after absorption.

610. 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 clinical testing in humans.

611. Phase II is performed after there is preliminary evidence that the drug is effective.

612. Low-dose/mid-dose/high-dose groups are three groups of animals which receive


different concentration (s) of the medication understudy.

613. A Biology lab technician works with living organisms.

614. 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.

615. Drug Metabolism describes the chemical reactions catalysed by enzymes that
change drugs into compounds which are easier to eliminate.

616. take part is the first phase in which patients with the target disease or disorder.

617. The active ingredient can be tested in humans only after these tests have been
successfully completed and authorization has been given.

618. Drug absorption is the movement of a drug from its site of administration into the
blood.

619. Drug metabolism describes the chemical reactions catalysed by enzymes that
change drugs into compounds which are easier to eliminate.

620. Drug distribution is the movement of drugs throughout the body after absorption.

621. Adverse reaction refers to all abnormal and unintended responses to an


investigational medicinal product. It is related to the dose administered

622. An adverse event 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.

623. 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

624. The active ingredient currently being tested seems to affect the kidneys.

625. A chemistry lab technician assists chemists and chemical engineers using
chemicals and related products
626. A biology lab technician works with living organisms

627. A control group in preclinical studies is a group of test animals that is not exposed
to the medication under study.

628. A control group in preclinical studies is a group of test animals that is not exposed
to the medication under study

629. in vivo studies that are conducted on whole, living organisms, usually animals,
including humans, and plants as opposed to a partial or dead organism.

630. In vivo studies that are conducted on living organisms

631. During the preclinical development of a drug, laboratory tests document the effect
of the investigational drug in living organisms (in vivo), and in cells in a test tube
(in vitro)

632. The results of preclinical testing are used by experts in pharmaceutical methods to
determine how to best formulate the drug for its intended clinical use

633. 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 clinical testing in humans.

634. The results of all testing must be provided to the MHRA in the United Kingdom
and/or other appropriate regulatory agencies in other countries in order to obtain
permission to begin clinical testing in humans.

635. First of all, it is the intention of the company to complete the preclinical trials by
the end of the year.

636. Regulatory agencies have to give permission before clinical testing can be
conducted in humans.

637. Extensive documentation must be provided to the appropriate regulatory


authorities.

638. A drug intended to act on the skin can be formulated as a cream.

639. The requirements of drug bioavailability determine how it will be administered to


humans.

640. Could somebody please fill me in on what the problem is ?

641. Phase I trials are studies which are performed to evaluate the safety of drugs in
healthy people and to determine the pharmacological properties of drugs
642. Phase II trials are controlled studies conducted to evaluate the effectiveness of the
drug in a particular indication and to determine possible side effects and risks. In
this phase, testing determines the safety and efficacy of the drug in treating the
condition and establishes the minimum and maximum effective dose.

643. Phase III is performed after there is preliminary evidence that the drug is effective.

644. Phase II is the first phase in which patients with the target disease or disorder take
part.

645. Phase III is the final phase before getting marketing approval

646. Phase IV trials are post-marketing studies after getting approval for general sale.
They are carried out in order to gather further information about the drug’s safety,
efficacy, and optimal use.

647. Dogs are more sensitive to drugs than mini-pigs

648. Choose the incorrect statement about clinical trials: Clinical trials are mainly aimed
at providing medication to terminal ill patients

649. Participating in clinical trials is a good way to earn some extra money

650. The overall benefit-risk of the drug must be evaluated

651. A control group receives either standard medication or a placebo

652. An inert tablet is called placebo

653. An adverse event is any abnormal medical occurrence in a patient or clinical trial
subject after a medicinal product has been administered .

654. 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 administer to
humans.

655. 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 clinical testing in humans.

656. In the preclinical stage of drug development, a(n) investigational drug must be
tested extensively in the laboratory. This is to ensure it will be safe to administer to
humans.

657. Regulatory agencies require testing that documents the characteristics - chemical
composition,purity quality,and potency -of thedrug’s active ingredient,and of the
formulated drug.(= strength)

658. Regulatory agencies have to give permission to commence with the clinical testing
in humans.
659. First of all, it is the intention / goal / aim of the company to complete the
preclinical trials by the end of the year : all of the above

660. Low-dose/mid-dose/high-dose groups are three groups of animals which receive


different concentration (s) of the medication understudy.

661. A control group 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.

662. The general health and behaviour of the dogs were checked twice a day.

663. On Day 2, abnormalities regarding food consumption were observed shortly after
administration in the high-dosegroup.

664. 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.

665. Phase II is the first phase in which patients with the target disease or disorder take
part.

666. Phase III Trials: 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.

667. Phase IV Trials: They are carried out in order to collect further information about
the drug’s safety, efficacy, and optimal use.

668. Phase II is performed after there is preliminary evidence that the drug is effective.

669. The safety and efficacy of a drug can only be determined by conducting rigorous
clinical trials, according to the FDA.(= very thorough and strict)

670. The parents of a 21-year-old woman challenged the FDA.They took the authority to
court after their daughter had died of cancer.

671. The safety and efficacy of a drug can only be determined by conducting rigorous
clinical trials, according to the FDA.

Tuần 8

672. The Drug Safety department is responsible for: Reporting an adverse drug reaction
to health authorities / Responding to a physician’s report about adverse drug
reactions.

673. The Regulatory Affairs department is not responsible for : Reporting an adverse
drug reaction to health authorities / Responding to a physician’s report about
adverse drug reactions

674. The Regulatory Affairs department is responsible for: Compiling dossiers for
submission to authorities
675. The Drug safety department is not responsible for: Compiling dossiers for
submission to authorities

676. Pharmacovigilance is the practice of monitoring the effects of medical drugs after
they have been licensed for use, especially in order to identify and evaluate
previously unreported adverse reactions.

677. Pharmacovigilance is the practice where government agencies, pharmaceutical


companies, and healthcare professionals work together to monitor and evaluate
suspected side effects of medicines to improve the safety of drugs in use.

678. 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.

679. 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.

680. A serious adverse event threatens life, requires or prolongs hospitalization, or


results in death.

681. Someone has a(n) rash , that person has a lot of red spots on the skin.

682. Itching is an uncomfortable sensation in the skin that feels as if something is


crawling on the skin and makes the person want to scratch the affected area.

683. Irritation means general discomfort, bad feeling.

684. Hypotension is when blood pressure is lower than normal (e.g. A blood pressure of
80/60).

685. When someone has a blood pressure of 80/60, that person has Hypotension

686. Heart palpitations is/are the feelings of having rapid, fluttering or pounding heart,
triggered by stress, exercise, medication or, rarely, a medical condition.

687. Sleeplessness : insomnia

688. A report received from the patient’s sister indicated that she had history of
hypertension.

689. After having taken Mensamint, the patient experience (ed) headaches and
insomnia.

690. A report was received from a physician indicating that a woman had fainted after
developing a sudden, severe skin rash and inflammation all over her body.

691. The patient reported not having had anything to eat but a chocolate candy bar 4
hours beforehand.

692. After examining the patient , the attending physician discontinued Mensamint and
administered a strong sedative.
693. After 24 hours, all symptoms had subsided except for a mild skin irritation and the
patient was released from hospital.

694. A correlation between the patient's peanut allergy and this adserse event cannot be
ruled out

695. The patient's normal vital signs (pulse, blood pressure, respiratory rate and
temperature) were established before the surgery.

696. The EMEA is a European Union agency for the evaluation of medicinal products.

697. QPPV is a Qualified Person Responsible for Pharmacovigilance.

698. Maybe the side effect was a result of taking this product : The side effect could
have been due to taking this product

699. old illness : pre-existing conditions

700. Pharmacopeia is an official publication containing a list of drugs with their effects
and directions for their use.

701. In order to get approval to sell a new drug, a company has to compile detailed
documentation with all the information required by the drug authorities.
Administrative Data include(s): general information, such as the marketing
authorization application form, as well as product characteristics and labelling

702. In order to get approval to sell a new drug, a company has to compile detailed
documentation with all the information required by the drug authorities. Non-
clinical Study Reports include(s): study reports, pharmacology, pharmacokinetics,
toxicology, and references

703. PIL : Patient information leaflet

704. Important information for any person taking a drug found in: Patient information
sheet / Patient leaflet / Package insert - All of the above

705. A patient can find Important information about a drug in: Patient information sheet
/ Patient information leaflet / Patient leaflet - All of the above

706. 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.

707. 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.

708. Choose the incorrect statement about Counterfeit drugs : Counterfeit drugs are not
fake drugs

709. A child may find a pill hard to swallow


710. If symptoms persist, the patient should consult a doctor.

711. This medicine has a bitter aftertaste

712. The patient had a pre-existing condition when he took the medication.

713. A(n) abdominal pain is the pain in your stomach or intestines.

714. At the hospital, the patient showed evidence of hyperactivity , accompanied by


confusion and agitation.

715. Government agencies, pharmaceutical companies ,and healthcare professionals


work together to monitor and evaluate suspected side effects of medicines to
improve the safety of drugs in use

716. 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.

717. Ms Gallois, the well-known opera singer, lost consciousness 30 minutes before she
had planned to go on stage. ( = the condition of being awake and able to
understand what is happening around you)

718. contraceptive is a drug or method used to prevent a woman from becoming


pregnant when she has sex.

719. Serious adverse event (SAE) - an adverse event that threatens life, requires or
prolongs hospitalization, or results in death.

720. The patient's normal Vital signs (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.

721. If you feel dizzy , you feel that you are losing your balance and are about to fall.

722. If you faint, you lose consciousness for a short time, especially because you are
hungry, or because of pain, heat, or shock.

723. Do not take Mensamint TM if you are allergic to penicillin.

724. The patient has an allergy to peanuts

725. The evidence is inconclusive.The facts neither prove nor disprove this.

726. In order to get approval to sell a new drug, a company has to compile detailed
documentation with all the information required by the drug authorities

727. We do need to let patients know of any possible side effects. But, it is not necessary
to alarm them unnecessarily.

728. When describing possible side effects for products in the pipeline, we will need to
differentiate more clearly between common and rare risks.
729. A high-profile person or a high-profile event attracts a lot of attention or publicity.
(= famous)

730. Our patients shouldn’t be so alarmed that they are afraid to actually put the pills in
their

731. It has the same packaging, same colour coating, same bitter aftertaste, but not the
same ingredients inside the pill. Is this a fake drug?

732. In Europe, steps have been taken to use holograms to prove a pharmacopeias
authenticity.

733. Excipient is an inactive substance that serves as the vehicle or medium for a drug
or other active substance.

734. A(n) fatal accident or illness causes someone's death.

Tuần 9
735. A four year old boy was found dead after he had stuck a highly potent, pain
relieving patch to his leg.

736. 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 cap so that the
contents remain dry.

737. A sachet is a small disposable bag containing an individual dose of the medicine. It
often has a lengthwise perforation which can be torn open.

738. The wet granules are pressed through a Sieve on their way to the fluid bed dryer.

739. The dried granules are stamped into a mould to form tablets.

740. 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
conten (s) are used up. Sometimes a desiccant is integrated into the cap so that the
conten (s) remain dry.

741. The moisture is removed by the hot air in the fluid bed dryer.

742. A first layer must be peeled off a blister before the drug can be pushed through the
second layer: peel-push system (Container system

743. A drum holds the pressed tablets until it is time to coat them.

744. effervescent tablets are uncoated tablets containing substances that react in the
presence of water and give off carbon dioxide.

745. A(n) sachet is a small disposable bag containing an individual dose of the medicine.
It often has a lengthwise perforation which can be torn open.
746. If someone is convict (d) of a crime, they are found guilty of that crime in a law
court.

747. Well, we have to make sure that there are no mix-up (s) (mistake) of materials
throughout the whole manufacturing process.

748. Safety goggles are used to protect your eyes are you work in the lab such as
chemical splashes/spills.

749. Primary packaging is the material which is in direct contact with the product.

750. During the manufacturing process, technicians also check the samples for content
uniformity, content weight, and so on.

751. A(n) 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
cap so that the contents remain dry.

752. In the Excess powder remover, 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.

753. 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 cap so that the
contents remain dry.

754. Lab equipment should always be clean or sterile and calibrate (d) before using it.

755. The granules are air-dried in the Fluid bed dryer.

756. dispenser is a machine/ mechanism which releases its contents in defined


amounts.

757. Safety is the freedom from danger or harm.

758. A tube that can only be released by an adult-length finger by pushing an internal
catch.

759. humidity is the amount of water vapor in the air

760. A(n) 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 foil. The product is removed by
pushing it through the foil.

761. In a "push-screw" container system, a closure must be pushed down before it can
be unscrewed.

762. 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 overdose.
763. The dried granule s) are stamped into a mould to form tablets.

764. rubber gloves protect hands from chemical compounds

765. If you give instructions in a very direct way, it may not sound polite.

766. Slide container system is a container with three buttons that must be align ed) in
order to slide off the lid .

767. A sachet is a small disposable bag containing a(n) individual dose of the medicine.
It often has a lengthwise perforation which can be torn open.

768. A drum holds the pressed tablets until it is time to coat them

769. 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 foil. The product is removed by
pushing it through the foil

770. The boy's death highlighted a problem that no one had anticipate (d) up to that
time .

771. lab coat protects the scientist and the scientist's clothes from hazardous or hot
chemicals

772. A(n) Inhaler 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.

773. Pharmaceutical companies have to comply with GMP guidelines

774. During the manufacturing process, technicians also check the samples for content
uniformity, content weight, and so on.

775. Please mind the corrosive substances, which could cause severe burns.

776. Which primary packaging is the most suitable for ointments? Tube

777. In order to receive valid and reliable results, all devices and methods have to
undergo a validation process.

778. Which primary packaging is the most suitable for nose drops? bottle

779. A vacuum system sucks up the excess powder.

780. Secondary packaging is any packaging material that is not in direct contact With
the product.

781. premises is a place where company has its offices and/ or factories.

782. A shaker loosens the excess powder.


783. A few years ago, a mother was convicted of negligence leading to her son's death. (
= Failure to take proper care over something/someone)

784. 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- accessible.

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

786. A hard hat must be worn at all times in this area to protect your head.

787. A(n) sticky label 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.

788. GMP covers how to design and construct buildings so that the flow of materials is
optimize (ed), and so that they can be cleaned easily.

789. Dry ingredients are weighed and transported to the granulator by the Hoist.

790. childproof means a child cannot open it alone.

791. A tube that can only be released by an adult-length finger by pushing an internal
catch. poke (Container system)

792. The dried granules are stamped into a mould to form tablets in the Tablet press.

793. Nowadays, RRB is a research-driven,innovative pharmaceutical enterprise that


develops new drugs, produces them, prepares them for sale, and markets them
worldwide.

794. Security is the protection from threats, such as attacks or crime.

795. In the Granulator, the ingredients are mixed to create a wet mixture.

796. A mother was sentenced to several years' community service for leaving a used
medical patch in a place where her young son could have access to it.

797. A closure must be pushed down before it can be unscrewed : push-screw


(Container system)

798. The elderly must have easy access to their medication,i.e.it needs to be elderly-
accessible.

799. Safe-disposal boxes should be included in the packages of medicated patches.


These boxes should have a small slit at the top to discard used patches and it
should be impossible to open them.

800. A closure must be squeezed between two fingers before it can be unscrewed :
squeeze-screw (Container system)
801. Because of her son's death, the young mother demand (ed) that safe-disposal boxes
be included in the packages of medicated patches.

802. Pharmaceutical companies have to comply with GMP guidelines.

803. A(n) syringe is a needle attached to a plastic tube used for putting medicine into
the body or removing blood.

804. In the meantime, requirements have reached a very high standard.

805. When it was founded, the company only had one production site.

806. During the safety film, I will give you more detailed information on the company.

807. Once the tour is finished, you will have seen the most important production areas.

808. The clothing specifications didn’t use to be documented.

809. The company’s safety regulations didn’t use to be so strict.

810. The company’s safety regulations didn’t use to be so strict.

811. Dry ingredients are weighed and transported to the granulator by the hoist.

812. In the granulator, the ingredients are mixed to create a wet mixture.

813. The granules are air-dried in the fluid bed dryer.

814. The excess powder is loosened by a shaker

815. In the tablet press, the dried granules are stamped into a mould to form tablets.

816. Primary packaging is the material which is in direct contact with the product.

817. Secondary packaging is the material which is not in direct contact with the product.

818. A(n) sachet is a small disposable bag containing an individual dose of the medicine.
It often has a lengthwise perforation which can be torn open.

819. A(n) inhaler 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.

820. A(n) syringe is a needle attached to a plastic tube used for putting medicine into
the body or removing blood.

821. A(n) sticky lable 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.
822. 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 cap so that the
contents remain dry

823. A sachet is a small disposable bag containing an individual dose of the medicine. It
often has a lengthwise perforation which can be torn open.

824. What type of packaging material is a syringe ? Primary

825. What type of packaging material is a sachet ? Primary

826. Which primary packaging would you recommend for nose drops ? bottle

827. Which primary packaging would you recommend for ointments ? tube

828. Which primary packaging would you recommend for oral tablets ? blister pack

829. Which primary packaging would you recommend for eye drops? bottle

830. To use a blister pack, you push through it.

831. A patient needs to press an inhaler to use it.

832. Choose the CORRECT matching of packaging material and the verb used to describe
how to use them: a jar - twist

833. A lot of research is done to make packaging childproof ,i.e. a child cannot open it
alone.

834. In a push-screw container system, a closure must be pushed down before it can be
unscrewed.

835. In a peel-push container system, a first layer must be peeled off a blister before the
drug can be pushed through the second layer

836. In a slide container system, a container with three buttons that must be aligned in
order to slide off the lid.

837. security : Protection from threats, such as attacks or crime

838. Our documentation must be improved to meet the requirements of the regulatory
authorities.

839. If a pill has a brightly-coloured coating a child may mistake it for a sweet.

840. Uncomplicated : simple

841. Nowadays, RRB is a research-driven, innovative pharmaceutical enterprise that


develops new drugs, produces them, prepares them for sale, and markets them
worldwide.
842. effervescent tablets are uncoated tablets containing substances that react in the
presence of water and give off carbon dioxide.

843. A hard hat must be worn at all times in this area to protect your head.

844. Safety is the freedom from danger or harm

845. If you give instructions in a very direct way, it may not polite.

846. The moisture is removed by the hot air in the fluid bed

847. A jar is a multi-use glass container with a twist-on lid. Sometimes a(n) desiccant is
integrated into the cap so that the contents remain dry.

848. huminity is the amount of water vapor in the air

849. A sachet is a small disposable bag containing an individual dose of the medicine. It
often has a lengthwise perforation which can be torn open.

850. child proof means a child cannot open it alone.

851. Because of her son's death, the young mother demand (ed) that safe-disposal boxes
be included in the packages of medicated patches.

852. Safe-disposal boxes should be included in the packages of medicated patches.


These boxes should have a small slit at the top to discard used patches and it
should be impossible to open them.

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