Predicting Physical Stability in Q1A(R)

12/3/01


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Table of Contents

Predicting Physical Stability in Q1A(R)

Stress Testing of Drug Substance

Batch Selection of Drug Product

Test Specification

Room Temperature Storage Conditions

Low Temperature Storage Conditions

Significant Change Criteria

Consequence of Significant Change

Shelf Life Establishment

Predictability of Physical Stability

Author: Chi-wan Chen