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药物稳定性 348条(本栏目收费,不能显示细节,电话13136136841)

2.10. Evaluation 395

2.11. Stability information 397

2.12. Reliability of minimum shelf lives 399

2.13. Extension of the derived minimum shelf life 400

3. Performance 400

3.1. Solid dosage forms: tablets, capsules 401

3.2. Semisolid dosage foms: creams, ointments 405

3.3. Solutions, ampoules 407

4. Stability Information for Comparator or Reference Products 409

5. Stability Testing with Pivotal and Bioequivalence 410

6. Time to Availability of Stability Information 411

7. Required Capacity 411

8. Summary 412

12.References 413

l. Introduction: The Strategic Planning 416

2. Step 1: Stress and Accelerated Testing with the Drug Substance 421

2.1. Objective 421

2.2. Application of the basic principles 425

2.3. Practical examples 426

3. Step 2: Preformulation and Formulation Finding for the Toxicological and Clinical Samples, Final Dosage Form 432

3.1. Objective 433

3.2. Application of the basic principles 433

3.3. Practical examples 434

1. Stability Is an Essential uality Attribute for Drug Products 2

3.Antioxidants 128

4.Other Work 129

4.References 130

1. Catalysis 133

2. Complexation 134

2.1. Complexing agents 138

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