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Accelerating Pharmacokinetic/Pharmacodynamic Drug Development

Barnett International , Arlington, VA
March 25-26, 1999

Invited Speakers: First-Time Ever for Comprehensive Industry Coverage!
DuPont Pharmaceuticals
Glaxo-Wellcome, Inc.
Amgen, Inc.
Guilford Clinical Pharmacology, UK
Janssen Research Foundation
MDS Harris, Inc.
Otsuka America Pharmaceuticals, Inc.
Astra Arcus AB, Sweden
Hoffman-La Roche, Ltd. Canada
Pharmaceutical Research Associates

Program:
**SPECIAL REGULATORY COVERAGE**

The FDA, Population PK/PD Modeling and Clinical Applications
Dr. Ken Kobayashi, Medical Officer, Office of Drug Evaluation, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Pharmacodynamic Endpoint Bioequivalence: Simulation Study on
Trial Design and Analysis
Chuanpu Hu, Senior Staff Fellow, Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

The Population Approach and Regulatory Submissions
Ene I. Ette, Ph.D., FCP, FCCP
Vertex Pharmaceuticals, Inc.

In-depth Sessions on Successful Accelerated Clinical Development:
* Successful Use of Biomarkers and Surrogate Endpoints
* Optimizing PK/PD Population Studies
* Effective PK/PD Modeling and Design
* Accelerating PK/PD Drug Development
* Genotyping to Improve PK/PD Analyses During Drug Evaluation and Development

Registration :
Early Registration Discount! Save $200 if payment is received before February 19, 1999. Call 1-800-856-2556 to register.

Deadline for Abstracts: N/A

Email for Requests and Registration: customer.service@parexel.com


Posted by: Joanie Kalin Host: parexel.com date: January 28, 1999 16:14:51
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