1. Drug Regulation, Development, Names, and Information Chapter 3 Copyright (c) 2004 Elsevier Inc. All rights reserved.

2. Drug Regulation, Development, Names, and Information Federal Pure Food and Drug Act—1906 Food, Drug and Cosmetic Act—1938 Kefauver-Harris Amendments—1962 Controlled Substances Act—1970 Food and Drug Administration Modernization Act—1997 Copyright (c) 2004 Elsevier Inc. All rights reserved.

3. New Drug Development Stages of drug development –Preclinical testing –Clinical testing Copyright (c) 2004 Elsevier Inc. All rights reserved.

4. Preclinical Testing Required before a new drug may be tested in humans Drug evaluated for –Toxicities –Pharmacokinetic properties –Potentially useful biologic effect – May take 1 to 5 years May be tested on humans after sufficient preclinical data are collected Copyright (c) 2004 Elsevier Inc. All rights reserved.

5. Clinical Testing There are four phases –Phase I Normal volunteers Evaluation of drug metabolism Effects on humans Copyright (c) 2004 Elsevier Inc. All rights reserved.

6. Clinical Testing (cont.) Phase II and Phase III – Tested in patients –Determine therapeutic effects –Dosage ranges –Patient safety –Total number of subjects—500 to 5000 –Duration of phases—3 to 6 months –After Phase III, application for conditional approval is made Copyright (c) 2004 Elsevier Inc. All rights reserved.

7. Phase IV: Postmarketing Surveillance –With conditional approval from the FDA, Phase IV begins –Usage is for the general population –New side effects may be discovered –Voluntary reporting by health professions is essential Copyright (c) 2004 Elsevier Inc. All rights reserved. Clinical Testing (cont.)

8. Limitations to Testing Procedure Women – FDA 1990s Children Copyright (c) 2004 Elsevier Inc. All rights reserved.

9. Drug Names Chemical name Chemical description of the drug Generic name Assigned by the United States Adopted Names Council Trade name Proprietary or brand name Copyright (c) 2004 Elsevier Inc. All rights reserved.