Invited Speakers: First-Time Ever for Comprehensive Industry Coverage!
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
**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
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: email@example.com