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U.S. Department of Health and Human Services

Science & Research

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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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