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Module 2.6: Nonclinical Written and Tabulated Summary 2.6 ...

Module 2.6: Nonclinical Written and Tabulated Summary 2.6 ...

www.mhlw.go.jp

CONFIDENTIAL CTD Module 2 Section 2-6-2_Pharmacology Written Summary, Page 1 Module 2.6: Non Clinical Summary 2.6.2 PHARMACOLOGY WRITTEN SUMMARY TABLE OF CONTENTS

  Clinical, Summary, Module 2, Module, Clinical summary 2, 2 summary

7. INVESTIGATOR’S BROCHURE

7. INVESTIGATOR’S BROCHURE

www.med.upenn.edu

An example of the Table of Contents is given in Appendix 2 7.3.2 Summary A brief summary (preferably not exceeding two pages) should be given, highlighting the significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information available that is relevant to the

  Clinical, Summary, 2 summary

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