1.4. Impact of API specifications | Know-How Academy

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Formulation Development for Generic Pharmaceutical Products

Introduction

0. Introduction (2:21)

1. Generic and brand

1.1. Drug components (7:44)
1.2. Brand and Generic (4:50)
1.3. Generic manufacturers role (3:35)
1.4. Impact of API specifications (7:52)
1.5. Impact of inactive specifications (6:44)
1.6. Impact of processing (4:26)

2. Generic product Development

2.1. Generic product development (9:51)
2.2. Know your company resources (6:55)
2.3. Preformulation (drug substance) (6:46)
2.4. Preformulation (Tablet) (8:42)
2.5. Preformulation (liquid) (8:31)
2.6. Preformulation (parenteral) (3:12)
2.7. Preformulation (references) (20:20)
2.8. Formulation Development (10:56)
2.9. Stability testing (14:31)

3. Scale up

3.1. Process applicability (11:57)
3.2. Prepare your documents (6:16)
3.3. Process validation (4:18)

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1.4. Impact of API specifications

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