Event

This introductory population PK training workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program. The material is structured to impart both the theoretical and practical aspects of the population approach and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. Examples of the use of population PK studies in drug development programs, especially those from the published scientific literature, will be presented whenever possible to provide specific details of various implementations and better illustrate essential aspects of population PK methods. Emphasis will be placed on compliance with the FDA’s Guidance for Industry on Population PK and the EMEA’s Guideline on Reporting the Results of Population PK Analyses; participants will gain an appreciation for the importance of protocol compliance, the essentials of accurate and sufficient data collection, and learn how to proactively plan in order to maximize study effectiveness.

Suzette Mis
Email: mis@buffalo.edu