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Module 2.6: Nonclinical Written and Tabulated Summary 2.6 ...
www.mhlw.go.jpCONFIDENTIAL 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
Module 2.7 : Clinical Summary 2.7.4 SUMMARY OF …
www.mhlw.go.jpCONFIDENTIAL CTD Module 2 Section 2-7-4_Summary of Clinical Safety, Page 4 2.7.4.1 Exposure to the Drug 2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies