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Book Categories |
List of contributors | ||
Introduction | ||
1 | Assay Validation and Inter-laboratory Transfer | 3 |
2 | Statistical Parameters and Analytical Figures of Merit | 15 |
3 | Overview of Worldwide Regulations | 75 |
4 | Issues Related to United States v. Barr Laboratories Inc. | 101 |
5 | Judge Wolin's Interpretations of Current Good Manufacturing Practice Issues Contained in the Court's Ruling in the United States v. Barr Laboratories | 119 |
6 | Bulk Drug Substances and Finished Products | 135 |
7 | Dissolution Studies | 169 |
8 | Robotics and Automated Workstations | 185 |
9 | Biotechnology Products | 209 |
10 | Biological Samples | 249 |
11 | Analytical Methods for Cleaning Procedures | 293 |
12 | Computer Systems and Computer-aided Validation | 303 |
Index | 339 |
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