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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 |
| Price | Condition | Delivery | Seller | Action |
| $104.00 | Digital |
| WonderClub |
James Mulder
reviewed Development and Validation of Analytical Methods, Vol. 3 on January 06, 2015
Development and Validation of Analytical Methods
Well researched, informative, confident in its language yet not inaccessible
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