ICH Guideline Q8 (R2) Pharmaceutical Development Part 1
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ICH Guideline Q8 (R2) Pharmaceutical Development Part 1
1 INTRODUCTION
1.1 Aim of the guideline
1.2 Scope
2. PHARMACEUTICAL DEVELOPMENT
2.1 Ingredients of the medicinal product
2.1.1 Active pharmaceutical ingredient
2.1.2 Other ingredients
2.2 Medicines
2.2.1 Formulation development
2.2.2 Exceedances
2.2.3 Physico-chemical and biological properties
2.3 Development of the manufacturing process
2.4 Container closure system
2.5 Microbiological properties
2.6 Compatibility
3. GLOSSARY
1 INTRODUCTION
1.1 Aim of the guideline
1.2 Scope
2. PHARMACEUTICAL DEVELOPMENT
2.1 Ingredients of the medicinal product
2.1.1 Active pharmaceutical ingredient
2.1.2 Other ingredients
2.2 Medicines
2.2.1 Formulation development
2.2.2 Exceedances
2.2.3 Physico-chemical and biological properties
2.3 Development of the manufacturing process
2.4 Container closure system
2.5 Microbiological properties
2.6 Compatibility
3. GLOSSARY
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