PHARMACOKINETIC AND PHARMACODYNAMIC METHODS IN
BIOMARKER DEVELOPMENT AND APPLICATION
Objectives
- Demonstrate how PK/PD models that incorporate biomarkers and surrogate endpoints can be
used to accelerate drug development
- Address novel PK/PD modeling approaches involving biomarkers and surrogate endpoints
- Suggest that PK/PD models can assist in evaluating the biological plausibility of
biomarkers
- Provide a forum for discussion on application of PK/PD principles to biomarkers and
surrogate endpoints
Agenda
| Moderators: |
Carl C. Peck, M.D., Georgetown University Medical Center |
|
Stephen C. Piscitelli, Pharm.D., National Institutes of
Health Clinical Center |
Introduction
Stephen C. Piscitelli, Pharm.D.
Case Studies
Modeling Hepatitis C Viral Dynamics and Interferon Treatment
Alan S. Perelson, Ph.D., Los Alamos National Laboratory
Pharmacokinetic/Pharmacodynamic Modeling and Simulation of Docetaxel Safety
Endpoints
René Bruno, Ph.D., Rhône-Poulenc Rorer Rercherche-Development, France
Monoamine Oxidase Type B Case Study
Jerry M. Collins, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug
Administration
Pharmacokinetic/Pharmacodynamic Population Model Linking Cortisol Production With
Fluticasone Concentration
Elena V. Mishina, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug
Administration
Panel Discussion With Audience Participation
Moderator: Carl C. Peck, M.D.
| Panelists: |
Arthur J. Atkinson, Jr., M.D., National Institutes of Health
Clinical Center |
|
Lawrence J. Lesko, Ph.D., Center for Drug Evaluation and
Research, U.S. Food and Drug Administration |
|
Paul Rolan, M.D., Medeval Co., United Kingdom |
|
Merrill Egorin, M.D., University of Pittsburgh Cancer
Institute |
|
Stephen A. Williams, M.D., Ph.D., Pfizer, Inc. |
Concluding Remarks and Formulation of Statement to Consensus Panel
Overview
Agenda Registration
Conference Abstracts
Hotel & Travel Selected References
Remote Video Conference Participation Contact
NIH Home Page
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