Drug Regulation, Development, Names, and Information

Drug Regulation, Development, Names, and Information Lecture notes

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


Drug Research
Identification of potentially useful chemical → Preclinical testing → development of research study → phase I → phase II → phase III / IV → Submission of New Drug Application (NDA) to FDA → Drug to market

New Drug Development
Stages of drug development
Preclinical testing
Clinical testing
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

Clinical Testing
There are four phases
Phase I
Normal volunteers
Evaluation of drug metabolism
Effects on humans

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 conditionalapproval is made

Clinical Testing (cont.)
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

Limitations to Testing Procedure
Women
– FDA 1990s
Children

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