c. Conducting plant studies d. None of the above

3. IND is required:

a. In case the drug is not intended for human subjects.

b. In case the drug is intended for in vivo testing.

c. When the drug is already approved and study is conducted within the approved

indication for use.

d. At the time of the clinical trial of an unapproved drug

4. Which CTD module is not required while filing INDA?

a. Module 4 b. Module 2

c. Module 3 d. Module 5

5. How many types of INDA are there?

a. 2 b. 4

c. 6 d. 3

6. The FDA will review and issue an approval, approvable, or non-approvable letter

within 180 days of receipt of application. This time period is known as:

a. Filing time frame b. Patent time frame

c. Review time frame d. None of the above

7. The term that denotes that a drug substance in two or more identical dosage forms

reaches the systemic circulation at the same relative rate and to the same relative

extent is known as:

a. Bioequivalence b. Bioavailability

c. Therapeutic value d. Absorption

8. It is a measure of the extent of absorption:

a. Cmax b. Tmax

c. AUC d. None of the above

9. The exemptions that are granted by USFDA from conducting human

bioequivalence studies are known as:

a. Clinical trial waivers b. Clinical waivers

c. Geowaivers d. Biowavers

INDA and NDA 141

10. Bioequivalence studies are not required in case of:

a. Drugs are parenterally administered b. Drugs in solution form

c. Drugs in gaseous form d. All of the above

11. Biowavers are given in case of:

a. Drugs are highly soluble and highly permeable.

b. Highest dose strength of the drug is soluble in 250 ml aqueous solution over a

pH 1–7.5 at 37°C.

c. 90% of the drug is absorbed if administered orally.

d. All of the above

12. Match the following

Form no Required for filing

a. Form FDA-356h i. INDA

b. Form FDA-3397 ii. Application to market a new drug, biologic, or an

antibiotic drug for human use

c. Form FDA-3331 iii. User fee cover sheet

d. 21 CFR, Sec. 312.23 vi. New drug application field report

or Sec. 312.20

13. Fill in the blanks

a. _________ IND is submitted primarily by companies whose main goal is to obtain

the approval for new drug marketing.

b. _________ IND is for the experimental drugs which show promising results in clinical

testing of life-threatening conditions.

c. After _______ days of receiving the application, the FDA will decide whether the

application may be filed or not. It is known as _________.

d. The main and major site of drug metabolism is ______.

e. ______is the observed maximum concentration of a drug.

f. _______ is a measure of the rate of absorption.

g. Bioequivalence studies are of two types such as __________ and ________.

ANSWERS

1. b 2. a 3. d 4. d 5. b 6. c 7. a 8. c

9. d 10. d 11. d 12. a (ii), b(iii), c(iv), d(i)

13. (a) Commercial, (b) Treatment, (c) 60, Filing time frame, (d) Liver, (e) Cmax,

(f) Tmax, (g) In vivo and In vitro.

142 Industrial Pharmacy