دانلود کتاب Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences)

فهرست مطالب :

Title Page......Page 2
Preface......Page 4
Acknowledgments......Page 6
Contents......Page 8
Contributors......Page 10
1. The Evolution of the Food and Drug Administration: Pre–New Drug Application Approval Inspection......Page 12
2. FDA’s Risk-Based Approach to Inspections......Page 38
3 .Critical Role of the Pharmaceutical Scientist in Product Development and Preparing for Pre-Approval Inspections......Page 70
4. Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspection......Page 94
5. The Systems-Based Pre-Approval Inspection......Page 106
6. A cGMP Risk Assessment and Management Strategy: Guidelines for the Pre-Approval Inspection......Page 118
7. Concepts in Quality by Design for Drug Development and Manufacture......Page 160
8. Equipment Cleaning During Pharmaceutical Product Development and Its Importance to Pre-Approval Inspection......Page 202
9. Conducting Stability Studies During Development to Ensure Successful Regulatory Approval......Page 218
10. Computer Systems Validation During the Drug Development Process in Anticipation of Pre-Approval Inspections......Page 236
11. Integral for Successful PAI: The Quality Assessment Program......Page 254
12. All Dressed Up but No Approval to Go:The Consequence of Failing an FDA Pre-Approval Inspection......Page 272
Index......Page 276