The phase I reactions are oxidation, reduction, hydrolysis, cyclization, decyclization.

Phase II: Synthetic/conjugation

In this phase, the metabolite is generally inactive.

The phase II reactions are glucuronide conjugation, acetylation, methylation, sulphate

conjugation, glycine conjugation, glutathione conjugation, ribonucleotide synthesis.

Inhibition of Drug Metabolism (Fig 8.5)

Fig. 8.5: Methods of inhibition of drug metabolism

128 Industrial Pharmacy II

PRACTICE QUESTIONS

Long Answer Type Questions

1. Explain the function of drug development team.

2. Explain in detail about non-clinical drug development. How is it different from

clinical drug development?

Short Answer Type Questions

1. Describe the types of non-clinical studies.

2. Explain drug development process with diagram.

3. What is toxicology? Explain the types of toxicological studies.

4. Explain drug metabolism in detail.

Objective Type Questions

1. Which of the following is one of the stages of drug development process?

a. Drug discovery and target validation

b. Pre-clinical testing

c. Investigational new drug application filing

d. Clinical studies (phase 1, phase 2, phase 3)

e. All of the above

2. INDA filing is done for:

a. Conducting animal studies b. Conducting human studies

c. Conducting plant studies d. None of the above

3. LD 50 stands for:

a. Legal dose 50 b. Lethal dose 50

c. Legitimate dose 50 d. None of the above

4. Who is responsible for filing INDA?

a. Sponsor b. Investigator

c. Monitor d. None of the above

5. The study helps in determine toxicity of the compound is known as:

a. Toxicology b. Pharmacodynamics

c. Drug metabolism d. None of the above

6. To detect possible interactions with chromosomes and DNA is known as:

a. Genotoxicity b. Carcinogenicity

c. Drug metabolism d. None of the above

7. Match the following

Name of stage of drug development process Order in the process

a. Drug discovery and target validation i. 4th

b. Pre-clinical testing ii. 1st

c. INDA iii. 2nd

d. Clinical studies iv. 3rd

e. NDA v. 6th

f. FDA review and decision vi. 7th

g. Phase 4 clinical studies vii. 5th

Drug Development and Non-Clinical Studies 129

8. Fill in the blanks

a. _________ is a process of bringing a new pharmaceutical drug to the market after

a lead compound has been identified by process of drug discovery

b. LD 50 is a parameter for determining _________.

c. Chemical alteration of drug in the body is defined as __________.

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

e. There are _________ phases of drug metabolism.

ANSWERS

1. e 2. a 3. b 4. a 5. a 6. a

7. a(ii), b(iii), c(iv), d(i), e(vii), f(v), g(vi)

8. (a) Drug development, (b) Toxic dose, (c) Drug metabolism, (d) Liver, (e) 2

130 Industrial Pharmacy II

9.1 GENERAL CONSIDERATIONS OF INVESTIGATIONAL NEW DRUG (IND)