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Guideline for the Preparation of Investigator’s Brochures

Johnson & Johnson Pharmaceutical Research & Development Guideline for the Preparation of Investigator s Brochures 10 July 2002 Prepared by: The Medical Writing Department Global Clinical Operations Investigator s Brochure Guideline 10 July 2002 2 TABLE OF CONTENTS GENERAL FORMAT AND CONTENT OF THE INVESTIGATOR S BROCHURE ..4 Title Page; Table of Summary ..5 List of Abbreviations and Definition of Terms ..5 MAIN TEXT OF THE IB ..6 1. 2. PHYSICAL, CHEMICAL, AND PHARMACEUTICAL PROPERTIES AND FORMULATIONS .. 6 3. NONCLINICAL STUDIES ..6 Nonclinical Pharmacology [Microbiology] ..6 Pharmacokinetics and Product Metabolism in Animals.

agencies to assess whether a proposed clinical study or group of studies is acceptable from a risk/benefit standpoint and to determine whether there are adequate data to justify the dosage regimen, duration, and other aspects of the proposed clinical trial(s). The IB provides investigators with sufficient background information to

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