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| Contributors | ||||||
| Foreword | ||||||
| Preface | ||||||
| 1 | The Laboratory Analyst's Role in the Drug Development Process [et al.] / Jonathan B. Crowther, William Lauwers, Sagar Adusumalli | 1 | ||||
| 2 | Laboratory Controls and Compliance / Henry Avallone | 31 | ||||
| 3 | The USP, ICH, and Other Compendial Methods / Jennifer G. Feldman | 49 | ||||
| 4 | Statistics in the Pharmaceutical Analysis Laboratory / Alvin J. Melveger | 77 | ||||
| 5 | Basic Analytical Operations and Solution Chemistry / Nicholas H. Snow, Wyatt R. Murphy, Jr. | 105 | ||||
| 6 | Spectroscopy / Perlette Abuaf, Alvin J. Melveger | 149 | ||||
| 7 | Chromatographic Principles / James M. Miller | 185 | ||||
| 8 | Gas Chromatography / James M. Miller, Harold M. McNair | 217 | ||||
| 9 | Liquid Chromatography: Basic Overview / Lee N. Polite | 255 | ||||
| 10 | HPLC Column Parameters / Richard Hartwick | 283 | ||||
| 11 | Dissolution / Ross Kirchhoefer, Rudy Peeters | 309 | ||||
| 12 | Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products / Jonathan B. Crowther, Paul Salomons, Cindi Callaghan | 331 | ||||
| 13 | Some Principles of Quantitative Analysis / James M. Miller | 371 | ||||
| 14 | Laboratory Data Systems / R. D. McDowall | 395 | ||||
| 15 | Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods [et al.] / Jonathan B. Crowther, M. Ilias Jimidar, Nico Niemeijer | 423 | ||||
| App. I | List of Symbols and Acronyms | 459 | ||||
| App. II | Glossary of Terms used in ICH Documents | 467 | ||||
| App. III | Universal Tests, Dosage-Form-Specific Tests, and Acceptance Criteria | 473 | ||||
| App. IV | USP Chromatographic Phases | 477 | ||||
| Index | 483 | |||||
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