Transcription of ASEAN GUIDELINE ON STABILITY STUDY OF DRUG …
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ASEAN GUIDELINE ON STABILITY STUDY OF DRUG …
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT (R1) Revision 25th ACCSQ-PPWG Protocol of STABILITY STUDY (example) 20 Report Format (example) 24 Reduced Design (Bracketing and Matrixing) 30 Examples of Types, Thickness and Permeability Coefficient of Packaging 32 Materials Decision Tree for Data Evaluation for Shelf-Life Estimation for Drug Products 34 (excluding Frozen Products) Examples of Statistical Approaches to STABILITY Data Analysis 35 6. GLOSSARY 36 7. REFERENCES 40 LIST OF CONTENTS Page1. INTRODUCTION 1 2.
1.5 The general conditions for long term stability testing in the ASEAN region are the Zone IVb conditions (30oC/75% RH). 2. OBJECTIVES This guideline is intended to provide recommendations on the core stability study package required for drug products, but leaves sufficient flexibility to encompass the variety of different
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