Đề Cương Ôn Tập Môn Tiếng Anh Chuyên Ngành Dược | Đại học Y khoa Phạm Ngọc Thạch

lOMoAR cPSD| 47207367
ĐỀ CƯƠNG ÔN TẬP MÔN TIẾNG ANH CHUYÊN NGÀNH DƯỢC THUẬT NGỮ
1. Dosage form (dạng bào chế): the final form of the medicine, e.g. tablet, power…
2. Over- the –counter drug (thuốc bán không kê đơn): a drug which can be sold without the patient seeing a doctor
3. Prescription drug (thuốc bán theo toa): medicine bought in a pharmacy and requiring
a written note from the doctor
4. SOPs: Standard operating procedures (qui trình vận hành chuẩn) are a set of written
instructions to maintain performance and results. They are the basis of good QA and QC system.
5. Research (nghiên cứu): the process of testing chemical compounds, with the goal of
finding a substance which has a beneficial effect on a targeted disease
6. Development (sự phát triển): the process of carrying forward discoveries made during
the research process, with the goal of producing a marketable drug
7. Chemist (chuyên gia hóa học/ dược sĩ trong tiếng anh anh): 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.
8. Toxicology (nghiên cứu về độc tính/ độc chất học): the study of potential risks to the body
9. Prescription (đơn thuốc): a piece of paper on which a doctor writes the details of the medicine that someone needs.
10.Pharmacology (dược lý): the study of drugs, how they work, and what they do in the body.
11.Tablet (viên nén): a hard, compressed medication in round, oval or square shape
12. Pill (viên thuốc): a small, round piece of medicine to be swallowed without chewing.
13.Pil stands for patient information leaflet (tờ hướng dẫn sử dụng thuốc): a form explains how to use drug
14.Syrup (si rô): a sweet, liquid medicine taken with a spoon or cup.
15.Quality assurance (Đảm bảo chất lượng) involves all manufacturing processes in
GMP which make sure the goods produced are kept at high standards.
16. Endpoint testing (thử nghiệm điểm cuối) is carried out at the end of every
manufacturing process to maintain quality standards
17.Product recall (thu hồi sản phẩm) even a product that has been marketed for years
might have to be taken off the market in a ___recall_______ if serious adverse reactions occur.
18.Traceability (truy xuất nguồn gốc): The documentation required for all research
processes and development steps ensures the _____safety_____ of a drug. 1 lOMoAR cPSD| 47207367
19.CAPA _ Corrective and Preventive Action ________ stands for Corrective
Action/Preventive Action. It is a part of the overall Quality Management System
(QMS) required for GMP. (hoạt động khắc phục/ hoạt động phòng ngừa-là 1 phần
của hệ thống quản lý chất lượng toàn diện bắt buộc cho GMP)
20.Preventive action (hoạt động phòng ngừa ): __ reduces or eliminates _______ prevents occurrence of errors
21.Corrective action (hoạt động khắc phục ): prevents recurrence of errors
22. Contaminated products (sản phẩm -thuốc bị nhiểm bẩn) are no longer pure and
acceptable for sale or public use and, therefore, must be returned to the manufacturer, or destroyed.
23.GAP stands for Good Auditing Practice (thực hành kiểm tra/đánh giá tốt)
24.GCP stands for Good Clinical Practice (thực hành lâm sàn tốt)
25.GDP stands for Good Documentation Practice (thực hành tài liệu tốt)
26.GLP stands for Good Laboratory Practice (thực hành phòng thí nghiệm tốt)
27.GMP stands for Good Manufacturing Practice (thực hành sản xuất tốt)
28.GRP stands for Good Research Practice (thực hành nghiên cứu tốt)
29.GSP stands for Good Safety Practice (thực hành an toàn tốt)
30.Audit (kiểm tra, đánh giá) An internal __audit________ involves inspection and
validation of operational methods, procedures, equipment to ensure functionality, accuracy and validity.
31.in vivo "in living organisms" thí nghiệm trên sinh vật sống
32.in vitro "in cells in a test tube" thí nghiệm trong ống nghiệm
33.Chemistry lab technician (Kĩ thuật viên phòng thí nghiệm hoá học) A
_technician_________ assists chemists and chemical engineers using chemicals and
related products ( …hỗ trợ các nhà hóa học và kỹ sư hóa học sử dụng hóa chất và các
sản phẩm có liên quan
34.Biology lab technician (Kĩ thuật viên phòng thí nghiệm sinh học) A
___biologist_______ works with living organisms. làm việc với sinh vật sống
35.Adverse event (Sự kiện bất lợi) 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. ________ là bất kỳ sự cố y tế bất thường nào xảy ra ở bệnh nhân
hoặc đối tượng thử nghiệm lâm sàng sau khi sử dụng sản phẩm thuốc. Nó không nhất
thiết phải có mối quan hệ nhân quả với sản phẩm thuốc.
36.Adverse reaction (Phản ứng bất lợi)___an adverse reaction _______ refers to all
abnormal and unintended responses to an investigational medicinal product related
to any dose administered. (-đề cập đến tất cả các phản ứng bất thường và không
mong muốn đối với một sản phẩm thuốc điều tra liên quan đến bất kỳ liều dùng thuốc.) 2 lOMoAR cPSD| 47207367
37.Preclinical studies: Nghiên cứu tiền lâm sàng
38.Regulatory Affairs: department is responsible for submitting documents needed to
obtain marketing approval for a drug. (phòng chịu trách nhiệm về các vấn đề pháp lý/ đăng ký thuốc)
39.Pharmacovigilance: 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. (Cảnh giác dược)
40.Side effect: (tác dụng phụ) A 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.
41.Serious adverse event: (Biến cố bất lợi nghiêm trọng)_a serious adverse
event_________ (SAE) is an adverse event that threatens life, requires or prolongs
hospitalization, or results in death.
42.Inflammation: Symptoms of __ inflammation ________ include: red, warm, and swollen. (viêm)
43.Hypertension: is when blood pressure is higher than normal (Cao huyết áp)
44.Itching: is when you feel like you want to scratch (ngứa)
45.Insomnia: is the condition of being unable to sleep (Chứng mất ngủ)
46.Active substance (Hoạt chất) The _active ingredient_________ of Mensamint TM is
mensagitatum. Other ingredients are peppermint, oil, sugar, talcum, and a preservative.
47.Primary packaging(Bao bì sơ cấp)__ primary packaging ________ is the material
which is in direct contact with the product.
48.Secondary packaging (Bao bì thứ cấp)__Secondary packaging ________ is any
packaging material that is not in direct contact With the product.
49.blister pack (vĩ thuốc)
50.syringe (ống tiêm, ống chích) A(n) __syringe ________ is a needle attached to a
plastic tube used for putting medicine into the body or removing blood.
51.Jar (lọ) 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.
52.Sachet (gói) 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.
53.Safety goggles (kính bảo hộ) __ Safety goggles ________ are used to protect your
eyes are you work in the lab such as chemical splashes/spills.
54.Lab coat (áo khoác phòng thí nghiệm) _ lab coat _________ protects the scientist and
the scientist's clothes from hazardous or hot chemicals 3 lOMoAR cPSD| 47207367
55.Rubber gloves:(găng tay cao su)__Rubber gloves ________ protect hands from chemical compounds)
56.Elderly-accessible: dễ tiếp cận cho người gia BÀI TẬP
I. Choose the correct answers
1. At the end of every stage of a product's manufacturing process, __________ is done
to maintain quality standards.
a. endpoint testing b. product recall c. product sampling d. traceability 2. GRP stands for__________
a. Good Research Practice b. Good Clinical Practice c. Good Auditing Practice
d. Good Documentation Practice
3. An information sheet explaining how to take drugs
a. PIL b. PILL c. PILS d. PILLS 4. Red, warm and swollen
a. palpitation b. rash c. inflammation d. itching
5. Blood pressure that is higher than is normal
a. palpitation b. rash c. inflammation d. itching
6. A product which can be sold without doctor's prescription
a. prescription drug b. over-the counter drug c. products in the pipeline d. dosage
7. A task performed to fix something wrong
a. corrective action b. preventative action c. clinical trial d. auditing
8. An unwanted medical occurrence during a clinical trial that threatens life and results in death
a. serious adverse event b. side effect c. adverse event d. adverse reaction
9. An examination of processes, procedures and standards a. research b. audit
c. in-man study d. development
10.The practice of making sure that goods and services fulfil defined standards.
a. quality assurance b. in-man study c. corrective action d. audit 11.The
final form of medication, e.g. tablets, powder, gel, spray, ect. a. Suppository b. dosage form c. aerosol d. inhaler
12.Trials to test a drug in humans
a. in-man study b. preclinical study c. product sampling d. approval process
13.Special kind of clothes people wear in laboratories a. overshoes b. overalls c. face mask d. hair covering
14. Paperwork necessary to provide evidence a.
documentation b. authority c. data d. administration
15.Monitoring or evaluating suspected side effects.
a. pharmacovigilance b. research c. quality control d. formulation 4 lOMoAR cPSD| 47207367
16.Wearing ..................to protect your legs in a laboratory
a. protective shoes b. rubber gloves c. rubber gloves d. safety goggles 17.A
careful study of a substance done before medicine is developed.
a. development b. research c. drug administration d. auditing 18.Not following
rules and regulations made by people in authority. a. rules
b. non-compliance c. up-to-date d. safety
19.To put a cover over tablets a. coat b. squeeze c. stick d. tear
20. A task performed to stop something bad from happening.
a. corrective action b. preventive action c. adverse event d. side effect 21.The
study of drug and the body's reaction to drugs.
a. preclinical technology b. toxicology c. pharmacology d. control study
23. ……is responsible for testing and organizing testing on live subjects and
ensure drugs are safe and effective a.
Research and development department b. Regulatory affairs b.
Clinical affairs d. Marketing and Sales
24. Permission to sell and distribute a new drug
a. marketing authorization b. properties c. dosage form d. new chemical entity
24. Giving off small bubbles of gas when added to liquids.
a. effervescent b. efficiency c. syringe d. blister pack
25. A prescribed amount of a medicine or drug. a. dosage form b. dosage
c. device d. properties
26. Features or characteristics of a drug. a. properties b. dosage
c. device d. properties
27. A smooth, thick substance to rub on the skin for healing
a. liniment b. ointment c. solution d. aerosol
28. …………..involves interim and product sampling procedures, which are carried out to check product quality
a. traceability b. quality assurance c. quality control d. product recall
29…………….procedures make sure that the health and well-being of laboratory workers are guaranteed.
a. observe b. checklist c. updated d. safety 30.
Paperwork necessary to provide evidence. a. documentation b. face mask c. overalls d. development
31. A substance recently develop 5 lOMoAR cPSD| 47207367 a. drug
b. solution c. new medical entity d. spray
32. An examination of processes, procedures and standards
a. in-man study b. clinical affairs c. audit d. rodent 33. A substance in a drug
a. tablet b. spray c. syringe d. ingredient
34. Trails to test a drug in humans
a. preclinical test b. in – man study c. sample testing d. test
35. A lot of spots on the skin
a. rash b. itching c. palpitation d. hypertension
36. The patient has………hypertension, heart trouble and insomnia.
a. a history of b. be ruled out c. suspected side effects d. correlation 37. …………is
drug is given for a certain number of doses or for a certain number of days. a. Standing order
b. PRN order c. Single order d. STAT order
38. A tube that can only be released by an adult –length ginger by pushing an internalcatch. a. squeeze crew b. poke c. push-screw d. slide
39. A container with three buttons that must be aligned in order to slide off the lid. a. slide
b. peel-push system c. poke d. push-screw
40. ………is a needle attached to plastic tube used for putting medicine into the body orremoving blood.
a. a jar b. a syringe c. a blister pack d. a sachet
41. Which of the following word does not belong to dosage form? a. capsules b. gel c. ointment d. prescription drug
42. Which of the following word does not belong to pharmaceutical documentation?
a. clinical reports b. dossiers c. marketing claims d. protocols 43.
Which of the following word does not belong to the drug research?
a. analysis of disease b. clinical trials c. drug safety d. discovery 44.
Which of the following word does not belong to the drug development? a. analytical testing
b. dosage forms c. target identification d. clinical trials
45. ……………….is the path by which a drug is taken into the body.
a. a route of administration b. drug order c. a right route d. OTC
II. Put the words in the right word order to make sentences
1. close, review Before we I'd like points to the action
2. needed be Charley's the will team new equipment describing
3. needs Each department me head get to to by back Friday
4. look at any need Finally, regulatory issues addressed that to be is going to Rasheed
5. from HR First will place in several pharmaceutical journals of all, job ads Iris Berger
6. by the end to finish the other is dosage forms Walter of the month 6 lOMoAR cPSD| 47207367
III. Complete the sentences using the correct form of the verbs in the box
be administered be conducted be determined
be formulated be provided be used
1. We started the trial after tests on investigational drugs _____________________ in vivo and
in vitro over a period of up to five years.
2. Last year, results of preclinical testing _____________________ to come up with the best
formulation of the intended drug.
3. Extensive documentation must _____________________ to the appropriate regulatory authorities.
4. A drug intended to act on the skin can _____________________ as a cream.
5. Potential risks to humans _____________________ in toxicity studies.
6. The requirements of drug bioavailability determine how it will _____________________ to humans.
IV. Read the memo and answer the questions Berner Pharmaceuticals Ltd BP - Interoffice Memorandum _ Date: Monday To:
Philip Reuter, Laboratory Management From:
Joseph Mason, Quality Assurance Internal Auditing Subject:
Annual audit of SOPs for laboratory safety
Cc: Richard Jacobs, Senior Quality Auditor; Gail Webber, Operations Auditor
Attachment: Audit checklist for laboratory systems and procedures (see p. 86)
This memo is to advise you that your department has been scheduled for a periodic audit of
the laboratory safety systems and procedures.
The timetable for the various laboratory audits is as follows:
Laboratory 1: Tuesday and Wednesday
Laboratory 2: Wednesday and Thursday
Laboratory 3: Thursday and Friday
Please make sure that all the laboratory staff are advised and prepared in accordance with
standard audit procedure. Two members of our audit team (Richard Jacobs and Gail Webber)
will begin this internal audit on Tuesday, two weeks from tomorrow, using the latest
company-approved audit checklist (see attachment).
The completed checklist and original audit results will be reviewed with you and the
Research and Development Vice President. Our goal is to identify any areas requiring 7 lOMoAR cPSD| 47207367
corrective or preventive action before a summary report of the status of these actions is
issued. This is done to assure compliance with industry standards, especially for safety procedures.
Please confirm receipt of this memo and send us a copy of all your correspondence with
regard to this scheduled audit. J. Mason
1. What kind of internal audit has been scheduled?
2. What is the objective of this audit?
3. How often does this type of audit have to be done?
4. When will the audit take place?
5. What documentation is necessary for the audit? 8