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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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