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THE ASEAN COMMON TECHNICAL DOSSIER …

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THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE registration OF PHARMACEUTICALS FOR human USE PART II: QUALITY 1 THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE registration OF PHARMACEUTICALS FOR human USE PART II: QUALITY TABLE OF CONTENTS Scope of the Guideline ........................................ ................... 2 Section A: Table of Contents ........................................ .......... 2 Section B: Quality Overall Summary ....................................... 2 Section C: Body of Data 9 1. Drug Substance ........................................ ................. 9 2. Drug Product ........................................ .................... 14 Section D: Key Literature References.

the asean common technical dossier (actd) for the registration of pharmaceuticals for human use part ii: quality

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