Special Pharmaceutical English Test: Unit 4 prt.

Fill in the blanks with the correct answer.

1. A drug that is being extensively tested to see if it is safe and effective against a disease is called
an___________________ drug.
2. How long does the preclinical testing stage usually last? From __________ to __________ years.
3. During the preclinical development of a drug, laboratory tests document the potential new drug in two
different mediums. They are:
a. ____________________________ or “in_________”.
b. ____________________________ or “in _________”.

Please circle the correct answer at the end of each sentence.

4. In the preclinical process, one of the responsibilities of CMC (Chemistry, Manufacturing & Controls)
Pharmaceutics is to find out how to best formulate the drug for its intended use. (True or False)
5. Pharmacology is the study of drugs and the body’s reaction to drugs. (True or False)
6. Toxicology studies the potential risks of an investigational drug to the body. (True or False)
7. In many cases, if a potential new drug efficiently passes all other preclinical tests, testing in live organisms
isn’t necessary before testing in humans. (True or False)

Vocabulary: Matching
8. to receive, to obtain___________ a. to proceed
9. to demand___________ b. to require
10. to ensure__________ c. potential
11. to define_________ d. to make sure
12. possible_______ e. determine
13. to continue______ f. to get

Verb or Noun? Circle the correct form of the word.

14. Regulatory agencies (permit/permission) in-man studies only after all preclinical studies have been
15. (documentation/documented) and approved. In the CMC (Chemistry, Manufacturing & Controls) sector,
16. scientists look for the best (formulate/formulation)for the drug according to
17. its (intended/intention)use.

18. Circle the correct answer

19. (Uncontrolled)(Controlled) clinical trials do not have a comparison group.
20. Abnormal & unintended response to an investigational medicinal product is called an adverse (event)(reaction).
21. There is a history of lung (disease) (illness) in the family.
22. Dogs are more (sensitive)(sensible) to drugs than mini-pigs.
23. He felt the (affect) (effect) of the new treatment immediately.
24. The new treatment (affected)(effected) his liver and kidneys.
25. (Shortly)(Briefly)after lunch our director spoke to us very (briefly)(shortly) about the new program.

Name one key feature about each Phase of clinical trials

26. Phase I _______________________________ 28. Phase III___________________________________

 27. Phase II_______________________________ 29. Phase IV____________________________

Describe two steps of a process from your work using the `Passive Voice´
30. ____________________________________________________________________________________________

31. ____________________________________________________________________________________________

Asking for information Making suggestions Responding to suggestions Explaining &

Could somebody fill me in
on…?
I’d like to know what has
happened.
Clarifying (“Double
check”)
Do I understand correctly…
you want me to…?
I have heard…is that
correct?
I suggest making… I’ll let you know what we justifying decisions
I suggest we take… come up with. We had no alternative
We could consider trying… I’m not sure I agree with but to…
So, we’d better test… you on that. I assure you…
You can (rest)
(be)assured that we
will…

Use the “Useful Language” to create a response in each situation.

32. While she was on maternity leave, the cleaning process for a machine was changed. She wants to know why it was
changed.
____________________________________________________________________________________________

____________________________________________________________________________________________.

33. An inspector has called your attention to a series of errors in the documentation for a process in your area. You
know that the mistakes were serious and have already retrained the employees who were responsible. Ensure the
inspector that is will not happen again.
___________________________________________________________________________________________

____________________________________________________________________________________________.

34. In a teleconference meeting someone says that another site is incompetent. You want to disagree firmly, but politely
_____________________________________________________________________________________________

_____________________________________________________________________________________________
.

35. The auditor asks for the deviation report on Metzomar tablets from granulation line I. “Double check” the auditor’s
request to clarify what he is asking.
____________________________________________________________________________________________.