ISAP Pre-Conference-Satellite-Symposium -
Preliminary Program

Pharmacokinetic / pharmacodynamic principles
in the drug development and marketing phase
   
Chairmen: W.A. Craig, J.W. Mouton, H. Derendorf
Thursday, September 9th, 8:30 AM

 

 

Norbert Schnitzler, BfArM, Bonn, Germany

"Requirements for dose optimisation, dose regimen and duration of therapy in the clinical development of antibacterial products: The new CPMP Guideline."

 

Hans Kemmler, Swiss Medic, Bern, Switzerland

"Dose optimisation for antibacterials, Theory, Science, and Regulatory Requirements: When Reality Strikes"

  Dan Weiner, Pharsight Corporation, Cary, North Carolina, USA

"Computer Assisted Trial Design to Improve HIV Drug Development - Optimisation of Phase II and III Research"

 

George Drusano, Albany, New York, USA
Hartmut Derendorf, Gainesville, Florida, USA

Summary Report from the Antimicrobial Drug Development Public Workshop

(organized by the the U.S. Food and Drug Administration (FDA; Department of Health and Human Services) and co-sponsored by ISAP and the Infections Diseases Society of America (IDSA))