Ta 3 [PDF]

Zitiervorschau

1. In the….. , workers test or organize testing on live subjects anh make sure that their drugs are safe and effective for the patients A. Clinical affairs B. Regulatory affairs C. Quality insurance D. Production 2. Richchard Moore is now working in the department of…. Affairs, BV Phaemaceutcal Company A. Quality B. Packging C. Production D. Regulatory 3. Over the counter drug is also called….drug A. Toxicity B. Adverse C. Planned D. Non prescription 4. We dont have the….perfected for the drops anh the syrups A. Time B. Technology C. Document D. Dosage 5. Charles Wu, from China will be connecting with us…. Vide conference A. By B. With C. Over D. In 6. Standard Operating Procedures is a description of a working method or… A. Process B. Way C. Aspect D. Field 7. Marie works as a… scientist. She develops pharmaceutical dosage forms A. Formulation B. Formula C. Formulate D. Form

8. A laboratory technicain often operates… scientific instrusment and performs test to determine wherther ingredients in liquid, powder, or tables meet requirement A. Difficult B. Hard C. Complex D. Tough 9. We firmly believe that we may have a good subtances to help us to develop a…. patch form of MensamintTM A. Time-consuming B. Time-release C. time-poor D. time-honored 10. In-depth knoweledge of….. regulations is essntial to be a clinical research associate A. National Heath Care Sevice B. Department of Packaging and Production C. Department of Quality Assurance D. Food anh Drug Administration 1. If a drug or medicine is not available “ over the counter ” , it normally means that a presciption from a physician is needed to obtain it from pharmacy A. T B. F 2. Laboratory technicians operate comples scientific instrusments and dertemine wherther liqids, powders , or tables meet requierments A. T B. F 3. Regulatory affairs develop pharmaceutical dosage forms A. T B. F 4. Prescription drug is a medicine bought in a pharmacy anh requiring a written note from the doctor A. T B. F 5. “on our medication” is the same with “taking our medication”

A. T B. F Once pharmacists have (1)… the industrial sector, (2)… is a lot of scope for moving “up or sideways” . says Halliday, who (3)… entered the industry (4)… a bench scientist directly after completing her PhD at the University of Strathlyde. She adds the mani¥y individuals start in laboratory – based roles anf the quickly progerss into other (5)…., (6)…. Quality asssurance If you want to work in research, (7)…. qualifications are essetial to prove your credentials but, for most roles, it is not necessary to have an advanced research degree, Halliday (8)… out. However, other roles will provide (9)… to study while you work and (10) …. Professtional development is expected. Including Points There Further Departments Opportunities Jioned Approprivate Herself As The main reason I am writing to you today is to remind you that we still need you to propose people from your departments to work on our new soft gel capsule for headaches and to liaise with your departments. As you know, it will be a prescription drug, so people with experience in analgesics are the ones we’d most like to have on board. Here is an update on the project. Since the conclusion of our successful feasibility study, we have also contained very encouraging preclinical data. “This” means that we can soon start with the clinical trials and are now ready to get the project team together. The kick-off meeting will take place on 6 March in the International Hotel. More details will follow soon.1. The receivers of the memo are ................ A. project managers B. project directors C. heads of departments

D. None is correct 2. Those who are proposed from their departments need to do ................ A. one thing B. two things C. three things D. four things 3. Those who are proposed from their departments need to ................ A. having knowledge and skills in medicines that relieve pains B. having knowledge and skills on board C. having knowledge and skills in a prescription drug D. having knowledge and skills in liaising with their departments 4. It can be inferred from the memo that their new soft gel capsule for headaches is ................. A. a drug B. a medicine C. an over the counter drug D. a prescription drug 5. The word “This” in paragraph 2 means................ A. an update on the project B. the conclusion of their successful feasibility study C. very encouraging preclinical data D. None is correct.

1. The Department of Research and Development finds new substances to make new drug ................. or change existing dosage forms. A. forms B. formulates C. formulas D. formulations 2. The most important reason for this memo is to ................. information about a new drug. A. talk B. take C. say D. give 3. “CoolHead” is just the ................. name of the new drug. A. working B. prescription C. generic D. compulsory 4. MensamintTM uses the newly synthesized ................. substance mensagitatum (Latin origin: the mind moves/aanimates). A. creative B. passive C. active D. captive 5. 68% of the patients currently take either tablets, pills, or capsules for various ................ .

A. ill B. ailments C. problems D. medication 6. We need to discuss ................. development of the new substance. A. far B. father C. farther D. further 7. Ointment is an oily ................. like a cream. D. substance A. substitute B. sustain C. subject 8. What kind of time frame are we taking about on the first ................. study? A. on man B. in man C. in-man D. on-man 9. US patients tent to ................. and buy drugs online. A. self-control B. self-taught C. self-study D. self-medicate 10. In Russia, when foreign companies try to introduce drugs, the Russians ask

them for good ................. training programmes. A. In pharmacy B. on pharmacy C. on-pharmacy D. in-pharmacy II. Read the sentence and decide if it is True (T) or False (F) by choosing the answer A or B. 1. Lotion is an oily substance like a cream. A. T B. F 2. Development is the process of testing chemical compounds, with the goal of finding a substance which has a beneficial effect on a targeted disease. A. T B. F 3. Development is the process of carrying forward scientific discoveries made during the research process, with the goal of producing a marketable drug. A. T B. F 4. Using the right dosage is especially important when giving medicine to children, because they often have problems swallowing pills. A. T B. F 5. Chemists and pharmacologists are also interested in how the medicine is administered, so they often ask about its prescription. A. T B. F 3 ENGLISH FOR PHARMACEUTICAL PURPOSES – CREDITS 5 & 6 III. Read the text below and choose ONE suitable word from the given ones to fill in each numbered blank. Protected Including

with

accurate

associate

collects

responsibility

requirement

importantly

subjects

A Clinical Research (1) .................. (CRA) has an important task within the clinical trial process. He/she has the key (2) .................. to verify that the safety,

rights and well-being of human (3) .................. are (4) .................. and that the reported clinical trial data are (5) .................., verifiable from source documents and complete. Most (6) .................., the CRA makes sure that the conduct of the trial is in compliance (7) .................. the recently approved protocol or amendment(s) protocol, with good clinical practice (GCP), and with applicable regulatory authority (8) ................... The CRA performs clinical site (hospital) monitoring and (9) .................. clinical research documents, (10) .................. clinical study protocol. You are probably aware that “CoolHead” is just the working name of the new drug. The soft gel capsule will be followed soon afterwards by two other dosage forms also in the pipeline: patches and sugar-coated tablets. 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. We still need project team members for R&D, Regulatory Affairs, and QA. As far as Marketing is concerned, Carole Marks will be flying in from France. She’ll give us more information on the marketing claims and a target patient profile. From Clinical Affairs in Italy, Anna Edicola will present the clinical requirements. She, as well as Charley Wu from Production, will be connecting with us by video conference. 1. “CoolHead” is ................ A. the working name of a new drug (A) B. a soft gel capsule (B) C. Both A and B are correct D. Neither A nor B is correct 2. Two dosage forms of “CoolHead”: patches and sugar-coated tablets ................ A. will be developed soon B. have been developed C. are being developed D. were being developed 3. All of these products are planned to apply for Food and Drug Administration (FDA) approval in the US .................

A. next year B. the following year C. the following year after they are launched in Europe D. all are correct 4. There are ................ departments in charge of the project. A. three B. four C. five D. six 5. Anna Edicola and Charley Wu will be ................ the face-to-face conference. A. present at (A) B. absent from (B) C. Both A and B are correct D. Neither A nor B is correct

IV. Read the memo and choose the answer A, B, C or D to fill in the blanks with missing information. 4 VIETNAM UNIVERSITY OF TRADITIONAL MEDICINE DEPARTMENT OF FOREIGN LANGUAGES – ENGLISH GROUP -----------***-----------SAMPLE TEST 3 I. Choose the best answer A, B, C or D to complete the following sentences. 1.Which phrase best describes the “GRP” in the pharmaceutical industry?

A. Good Reservatory Practice B. Good Research Practice C. Good Reservation Practice D. Good Researching Practice 2. Laboratory gowns or lab coats, latex gloves, and safety glasses ................. at all times. A. must be wear B. must be worn C. must wear D. must be wearing 3. I suggest that they also check the equipment lists to make sure each workstation ................. all the correct equipment. A. have B. had C. has D. having 4. If the auditors observe any ................., they will write it down on their checklist and we’ll be informed so that we can take corrective or preventive action. A. difference B. non-compliance C. failure D. fake data 5 Im working on trying to find ................. new substance which we hope to develop for pain relief. A. a B. the

C. some D. any 6. Endpoint testing is carried out at the end of every manufacturing process, which is to ensure that all procedures have been performed in compliance with industry and company ................. A. criteria B. curriculum C. standards D. targets 7. Inspection and validation are required to prove that manufacturing and testing equipment is ................. clinical B. functional C. approval D. fundamental 8. Manufacturing ................. and procedures must go through periodic validation to guarantee that they are still of an acceptable standard. A. approach B. process C. processes D. method 9. The ................. required for all research processes and development steps ensures the traceability of a drug. A. documentation B. traceability C. inspection D. validation 10. A holistic approach considers ............... processes and environments

together and not individually. A. laboratory and manufacturing B. laboratory C. manufacturing D. entire II. Read the sentence and decide if it is True (T) or False (F) by choosing the answer A or B. 1. To ensure that laboratory workers are asked certain questions about safety procedures, auditors use a checklist. A. T B. F 2. It is absolutely essential to move lab mice outdoors in closing cages. A. T B. F 1 3. Bleach must be used on all equipment following any experiments with laboratory animals. A. T B. F 4. If any non-compliance is observed during the audit, the department will be informed so they can take safety procedures. A. T B. F 5. Safety procedures make sure that the health and well-being of laboratory workers are guaranteed. A. T B. F III. Read the text and choose the answer A, B, C or D to fill in the blanks with missing information. The US only has two official categories for drugs: drugs needing a prescription and drugs that do not. The former are prescription drugs and are available in pharmacies and only by prescription. The latter are over-the-counter drugs which can be sold in any type of retail outlet that chooses to stock “them”. In general, in the US, medication must meet four criteria in order to obtain the status of 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- labeling that provides adequate directions for sale and effective use. 1. The official categories for drugs in the US are ................ A. prescribed and non- prescribed ones (A) B. those with and without a prescription (B) C. both A and B are correct D. neither A nor B is correct 2. ................ are available in pharmacies. A. those with a prescription B. those without a prescription C. OTC drugs D. all are correct 3. The word “them” in paragraph 1 refers to ................ A. official categories B. drugs needing a prescription C. retail outlets D. drugs that do not need a prescription 4. The word “it” in paragraph 2 refers to ................ A. the US B. medication C. criteria D. the status 5. To obtain the status of non-prescription or over-the-counter (OTC) product medication must meet four................

A. standards (A) B. principles (B) C. Both A and B are correct D. Neither A nor B is correct IV. Read the text below and choose ONE suitable word from the given ones to fill in each numbered blank. Check important

carried high

compliance manufacturing

ensures testing

sale every

The quality assurance process in good (1) .................. practice (GMP) includes product quality control, sampling, and (2) ................... Quality control (3) .................. that the product quality remains (4) .................. The reason for interim testing, or product sampling, is to (5) .................. the quality of pharmaceutical products. This is (6) .................. to make sure that the product is suitable for its intended use and for (7) .................. Endpoint testing is (8) .................. out at the end of (9) .................. manufacturing process. This is to ensure that all procedures have been performed in (10) .................. with industry and company standards. (88 words)

1. In the …. Workers test or organize testing on live subjects and make sure that their drug are safe and effective for the patients A. Clinical affairs B. Regulatory affairs C. Quality insurance D. Production

2. In the department of production, they compound the raw into drugs,…. Them and out in the leafters for the patients. A. Produce B. Study C. Test D. Package

3. The department ok production also keeps careful…. Of all the steps in the process A. Documents B. Records C. Numbers D. Data 4. The department of…. Plans the promotion and distribution of drugs which will launched A. Clinical affairs B. Regulatory affairs C. Marketing and sales D. Quality insurance 5. The department of marketing and sales is responsible for making… about the packaging or tablet colour of new product A. Experiments B. Decisions C. Regulation D. Lozenges 6. Richard moore is now working in the department of… affairs BV Pharmaceutical Company A. Quality B. Packaging C. Production D. Regulatory 7. The department of research ad development finds new subtances to make new drug…. Or change existing dosage forms A. Forms B. Formulates C. Formulas D. Formulations

8. The main resion Im writing to you is to get your input on a new… A. Product B. Person C. Data D. Decision 9. We plan tomake a new… drug for headaches A. Kind B. Prescription C. Working D. Complete 10.They still need me to propose people from my department to work… their new product for headache A. Up B. In C. On D. At 11.Over the couter drug is also called …. Drug A. Toxicity B. Adversre C. Planned D. Non - prescription 12. Patients… want to buy this kind of drug will not need see a doctor first A. who B. which C. whom D. whose 13. there are three dosage forms …. At the moment A. planning B. planned C. plan D. plans 14.the company plans to sell the drug …. Europe and the U.S A. on B. at C. in D. at

15.projects members from marketing, production, and clinical affairs ar already … board A. on. B. At C. In D. At 16.The most impartant reason for this memo is to… information about a new drug A. Talk B. Take C. Say D. Give 17.“Coolhead” is just the… name of the new drug A. working B. prescription C. generic D. compulsory 18.the… meeting for the first gathering of people who will work in this project will take place on March 6th in the international hotel A. final B. kick-off C. only D. most 19.…. Drug is a kind of medicine bought in a pharmacy and requiring a written note from the doctor A. experimental B. controlled C. over-the-counter D. prescription 20.after a lot of experiments , we obtained very encouraging… data A. precise B. original C. preclinical D. pipeline 21.…. Study is an investigation to determine the advantages , practically and profitabilityof a proposed project

A. B. C. D.

feasibility preclinical organized regulatory

22.we need project team members….. R&D , Regulatory Affairs, and AQ A. to B. from C. about D. for

23. in the department of regulatory affairs, they compile the… and send it to the regulatory drug authorities A. production processes B. preclinical data C. drug documentation D. patient records

24. the company needs to know which drug dosage forms patient…. ? A. like B. choose C. prefer D. take 25. I think we should consider…. A gel tablet…. A pill A. either..or B. either C. neither…nor D. neither

26.Halen just completed a patients survey in Swichland about hospital in paitient… dosage forms? A.Medicinal B.Medical C.Medicine D. Medication

27.Even a liqid form would be … than a patch A. Good B. Better C. Best D. Bad 28.…. Is the freedom from danger or harm A. saety B. security C. both a B D. Neither A B 29.What kind of dosage forms is most … by the patients survey Helen? A. prefer B. preferred C. prefers D. preferring

30. … have you been trained to perform this produce, David? A. What B. Who C. Which D. How

31. A lot of question about laboratory safety might be asked during an…. Audit procedure A. internal B. external C. superior D. interior

32.we are preparing for the laboratory safety prucedures internal audit…. Two weeks A. on B. in C. about

D. at 33.we need to discuss…. Development of the new substance A. far B. father C. farther D. further

34.mensamintTM uses the newly synthesized …. Substance mesagitaum A. creative B. passive C. active D. captive

35.…. Must be used on all equipment following any experiments with laboratory animals A. agents B. disinfectant C. substance D. sterilize

36.Small…. Spills must be covered with a paper towel and treated with bleach A. Chemical substance B. Sentences C. Compound D. Biological agent

37. A few years ago, a well-known European pharmaceutical copany was forced to recall one of its drugs due to claims of product….. A. contaminative B. contaminate C. contamination D. contaminator

38. the recall of that drug took place following reports from patients tha their medication hd a strange…. A. Oudur B. Color C. Taste D. Drug

39.…. Is an condition in which a part of the body becomes red, warm, and swollen A. adverse event B. inflamination C. side effect D. serious adverse event

40.a few patients experienced nausea immediately after… the medication A. making B. taking C. getting D. giving

41. immediate investigations showed that … of the tablets contained abnormally high levels of a harmful genotoxic substance A. examples B. trials C. experiments D. samples

42.….. of cleaning processes is essential in this industry , because chemical or bacterial contaminaotion of drug products can potentially lead to severe public heath risks A. validation B. sample C. value D. cleaning

43. no other products manufactured by the pharmaceutical company… by the mistake and the contamination error was qickly rectified A. is affected B. are affected C. was affected D. were affected

44. if the auditiors observes any… , they will write it down on their checklist and we will be informed so that we can take corrective or preventive action A. difference B. non-complicance C. failure D. fake data 45.I suggest that they also check the equipment lists to make sure each workstation …. All the correct equipment A. Have B. Had C. Has D. Having

46.May I just suggest that the junior lab technicians… these two items? A. Works B. Take care of C. Solve D. Take care on

47. Im working on trying to find…. New substance which we hope to develop for pain relief A. a B. the C. some D. any

48.would you please tell me which special …. Must be followed in the laboratory? A. Ways

B. Processes C. Procedures D. Methods

49. We have to… special lab coats, safety gloves, hairnets, and overshoes in the laboratory A. try B. take off C. try on D. wear

50.….. is the ability of drug to treat the illness for which it was developed. A. Efficacy B. Eddervescent C. Efficienty D. Effectiveness

51.In my opinion, the…. Studies for this drug will take more than six months A. In-men B. For-man C. For-men D. In-man

52. At the end of every stage of the products manufacturing process,…. Is done to maintain quality standards A. quality testing B. endpoint testing C. control testing D. trial testing

53. Quality control involes …. And product sampling procedures, which are carried out to check product quality A. interval B. interim C. internal

D. intercept

54.even a product that has been marketed fo years might have to be…. The market in a product recall if serious adverse reactions occur A. taken from B. taken over C. taken off D. taken up

55. manufacturing … and procedures must go through periodic validation to guarantee that they are stll of an acceptable standard A. approach B. process C. processes D. method

56. contaminated products are no longer pure and,… sale or public use and , therefore , must be returned to the manufacturer , or destroyed A. accepted for B. unaccepted for C. acceptalble for D. unacceptable for

57.The… required for all researchprocesses and development steps ensures the traceability of a drug A. Documentation B. Traceability C. Insprection D. Validation

58. A holistic approach considers… processes and environments together and not individually A. laboratory and manufacturing B. laboratory C. manufacturing

D. entire

59. endpoint testing is carried out at the end of every manufacturing process , which is to ensure that procedures have been performed in compliance with industry and company…. A. Criteria B. Curriculum C. Standards D. Targets

60.If the documentation is not …. , or if the required specifications are not met, then the product considered contaminated A. On place B. In place C. On order D. In order

61.Inspection and validation are required to prove that manufacturing and testing equipment is…. A. Clinical B. Functional C. Approval D. Fundamental

62. All operational methods and procedures must also be inspected for… A. accuracy B. accurating C. accurate D. accurated

63. our goal is to identify any areas requiring corrective and …. Action before a summary report of the status os these action is issued A. active B. passive C. preventive

D. productive 64.no smoking , drinking or eating is… in the laboratory A. allow B. allowed C. forbid D. forbidden

65. The complete checklist and… audit results will be reviewed with you and the research and development vice president A. original B. first C. draft D. only

66. The junior lab technicians will be cleaning the laboratories and checking the… equipment lists A. place B. base C. floor D. workstation

67. good sanitary hyglence must be… by all lab staff A. worked B. done C. made D. practiced

68. small biological …. Spills must be covered with a paper towed and treated with bleach A. act B. agent C. thing D. item

69.…. Is a solid medicine which melts slowly in the rectum or vagina A. aerosol B. solution C. suppository D. capsule