PHYS 7330 - Principles and Practice of Pre-clinical Drug Development (3 Credit Hours)

Lecture Contact Hours: 3
This course introduces key issues and aspects of developing a new small molecule or biological drug, with focus on the guidelines from regulatory agencies on the data required for the Investigational New Drug (IND) application. Major issues in Pharmacology, Toxicology, Safety Pharmacology, Pharmacokinetics and Chemistry, Manufacturing and Control (CMC) sections of the IND submission process are described. Practices of laboratory animal efficacy models, pharmacokinetics models, toxicology study protocols, master batch record generation and the concepts of Good Laboratory Practice (GLP)/Good Manufacturing Practices (GMP) will be covered, with particular emphasis on the Code of Federal Regulations Title 21 part 58, 210 and 211.

Restriction(s): NO Undergraduate Level Students
Repeat Limit: Not Repeatable