ICH Guideline Q8 (R2) Pharmaceutical Development Part-1
Channel: DR Technical Gyan
Date: 2020-12-08

ICH Guideline Q8 (R2) Pharmaceutical Development Part-1
1. INTRODUCTION
1.1 Objective of the Guideline
1.2 Scope
2. PHARMACEUTICAL DEVELOPMENT
2.1 Components of the Drug Product
2.1.1 Drug Substance 
2.1.2 Excipients
2.2 Drug Product 
2.2.1 Formulation Development
2.2.2 Overages
2.2.3 Physicochemical and Biological Properties
2.3 Manufacturing Process Development 
2.4 Container Closure System
2.5 Microbiological Attributes 
2.6 Compatibility
3. GLOSSARY