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Stability Study Management
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Stability Study Management
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INSTRUCTION FOR EVALUATION
Chapter
Definition and Objective
Need and aim of stability study
Systematic approach
ICH and Stability Guidelines
Purpose
Stress stability testing
Selection of Batches
Container closure system
Specifications
Testing Frequency
Stability study conditions
Storage condition
Evaluation of stability data
Significant Change
Bracketing and Matrixing
Global climatic zones
Stability chamber
Photo stability studies
Mean Kinetic Temperature
Stability Protocol
INSTRUCTION FOR EVALUATION
EVALUATION QUESTIONNAIRE
10 questions