ICH Q5E: Comparability of Biotechnological/Biological Products Changes in Manufacturing Process
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ICH Q5E: Comparability of Biotechnological/Biological Products Changes in Manufacturing Process
ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process INTRODUCTION 1.1 Objectives of the Guideline 1.2 Background 1.3 Scope 1.4 General Principles 2. GUIDELINES 2.1 Considerations for the Comparability Exercise 2.2 Quality Considerations 2.2.1. Analytical Techniques 2.2.2 ...
995 viewsMay 30, 2020
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