Executive Summary
Gender Studies in Product Development:
Scientific Issues and Approaches
November 1995
Table of Contents
Introduction
Charge to the Workshop
Historical Overview
- Women of Childbearing Potential and Early Clinical Trials
- Policy Changes: The 1993 FDA Gender Guideline and NIH Initiatives
Panel Discussions and Recommendations
- Panel I: Pharmacokinetics and Pharmacodynamics
- Panel II: Hormonal Influences
- Panel III: Study Design and Analysis
Public Hearing
FDA Recommendations: Strategies for Assessing
Gender Effects
In Summary
Acknowledgments
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