Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 17, 2003

Introduction to the Meeting, Dr. Lawrence Lesko, PhD, FCP, FDA (HTM) (PPT)

Proposal for End-of-Phase 2A (EOP2A) Meetings, Dr. Lawrence Lesko, PhD, FCP, FDA (HTM) (PPT)

End-of-Phase 2A (EOP2A) Meetings - Meeting Topics and Case Studies, Peter Lee, FDA (HTM) (PPT)

Benefits and Applications of Exposure Response Relationship in Drug Development and Approval - Case Studies, Dr. Ameeta Parekh, PhD, FDA (HTM) (PPT)

The Role of Exposure-Response Evaluation in Drug Development and Regulatory Decisions - Case Study: Rosuvastatin, Dr. Hae-Young Ahn, PhD, FDA (HTM) (PPT)

Could an EOP2A Meeting Shorten Drug Development Time?, Joga Gobburu, FDA (HTM) (PPT)

QT Study Design - Use of Clinical Trial Simulation, Peter Lee, FDA (HTM) (PPT)

Issues in the Simulation and Analysis of QTc Interval Data, Dr. Peter Bonate, PhD, FCP, ILEX Oncology (HTM) (PPT)

QT Evaluation Studies: Pharmacometric Considerations, Leslie Kenna, Peter Lee & Yaning Wang, FDa (HTM) (PPT)

Pediatric Bridging: Pediatric Decision Tree, Dr. Lawrence Lesko, PhD, FCP, FDA (HTM) (PPT)

Sotalol Pediatric Decision Tree and Exposure-Response Relationship, Peter Hinderling, OCPB (HTM) (PPT)

Case Study Merck's Singulair (Montelukast) Tablets, Dr. Tien-Mien Chen, PhD, FDA (HTM) (PPT)

Methods for Determining Similarity of Exposure-Response Between Pediatric and Adult Populations, Dr. Stella Machado, PhD, FDA (HTM) (PPT)

Presentation by Dr. Gregory Kearns, PharmD, PhD (HTM) (PPT)

Pediatric Drug Development and Extrapolation, Dr. William Rodriguez, MD, FDA (HTM) (PPT)

Questions (HTM) (PPT)