Food and Drug Administration

Pharmaceutical Science Advisory Committee

Clinical Pharmacology Subcommittee

October 23, 2002

Slides

Consideration of Investigational Pharmacokinetic Studies to Identify Patient Populations at Risk: Methods Used to Adjust Dose Given the Availability of Exposure-Response Information, Dr. Peter Lee, PhD (HTM) (PPT)

Methods to Adjust Doses Based on Exposure-Response Information Points to Consider, Richard Lalonde (PDF) (HTM)

Using Exposure-Response Relationships to Define Therapeutic Index: A Proposed Approach Based on Utility Functions, Dr. Jurgen Venitz, MD, PhD, FDA (PDF)

Topic #2: Use of Exposure-Response Relationships in the Pediatric Study Decision Tree: Questions to be Asked Using the FDA Pediatric Database , Dr. Rosemary Roberts, MD and Dr. Arzu Selen, PhD, FDA (PDF)

A Rational approach to Drug Development in Pediatrics, Dr. Rosemary Roberts, MD, FDA (HTM) (PPT)