Pharmaceutical Manufacturing

Question 1

1. List the stages in drug discovery process

Answer 1

1. DISCOVERY
2. PRECLINICAL DEVELOPMENT
3. PHASE 1 CLINICAL TRIALS
4. PHASE 2 CLINICAL TRIALS
5. PHASE 3 CLINICAL TRIALS
6. REGULATORY APPROVAL
7. APPROVED FOR MARKETING
8. POSTMARKETING SURVEILLANCE

Question 2

3. What is CDER and what is it function?

Answer 2

CENTER FOR DRUGS EVALUATION AND RESEARCH

The mission of FDA’s CDER is to assure that safe and effective drugs are available.

4 main areas of activity:

1. New drug development and review
2. Generic drug review
3. Over-the-counter drug review
4. Post drug approval activities (drug shortages, post marketing surveillance)

Question 3

4. Who are ICH and what is their function?

Answer 3

INTERNATIONAL COUNCIL FOR HARMONISATION Organisation which aim is a formulation of a joint regulatory industry initiative on the international harmonisation of drug regulations. It is composed of representatives from regulatory agencies and industry associations from US, EU and Japan.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.