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American College of Clinical Pharmacology:
Pre-Meeting Workshop 1
September 8, 2007
"Short Course on PKPD Modeling: Theory and Application to Therapeutic
Proteins and Macromolecules"
8:00 AM - 9:00 AM
Basic PD Models (Effect Compartment, Indirect Response): Theory, Examples
Jogarao Gobburu, Ph.D., FDA, Silver Spring, MD
9:00 AM - 10:00 AM
Introduction to Antibody PK/PD: Determinants of Mab Absorption,
Distribution, and Elimination
Joseph Balthasar, Ph.D., University at Buffalo, Buffalo, NY
10:15 AM - 11:15 AM
PKPD of Antibodies: Examples
Joseph Balthasar, Ph.D., University at Buffalo, Buffalo, NY
11:15 AM - 12:15 PM
Application to Development #1: From PK to PD and from animals to humans
Ivan Nestorov, Ph.D., Zymogenetics, Seattle, WA
Jogarao Gobburu, Ph.D., FDA, Silver Spring, MD
2:00 PM - 2:45 PM
Application to Development #2: Rational dosage regimen selection by modeling
and simulation
Ivan Nestorov, Ph.D., Zymogenetics, Seattle, WA
3:00 PM - 3:45 PM
Application to Regulatory Decisions: Trial Design, Approval
and Labeling
Jogarao Gobburu, Ph.D., FDA, Silver Spring, MD
Joseph Balthasar, Ph.D.
University at
Jogarao Gobburu, Ph.D.
FDA,
Ivan Nestorov, Ph.D.
Zymogenetics, 
Jogarao Gobburu, Ph.D., Director (acting) - Pharmacometrics, Food and Drug Administration (CDER), Silver Spring, MD Joseph Balthasar, Ph.D., Associate Professor of Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY Ivan Nestorov, Ph.D., Scientific Fellow, Zymogenetics, Seattle, WA
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