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PhRMA Perspective on Clinical Pharmacology Research in Pregnant Women

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Table of Contents

PhRMA Perspective on Clinical Pharmacology Research in Pregnant Women

Overview

The Problem

What Possibilities Does Clinical Pharmacology Hold?

What are the Limitations?

What are the Limitations? (continued)

What are the Limitations? (continued)

Industry Concerns

Which Drugs Should be Studied?

When in a Drug’s Lifecycle Should it be Studied?

When in a Drug’s Lifecycle Should it be Studied? (continued)

Who Should be Studied & When?

What Information Should be Obtained?

How Should Studies be Designed and Data Analyzed & Communicated?

Possibilities for the Future

Possibilities for the Future (continued)

Summary

Summary (continued)

Summary (continued)

The Ideal Goal

Author: Maria Palmisano, MD

Director, Clinical Pharmacology/Experimental Medicine, Bristol-Myers Squibb

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Last update: July 11, 2005

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