| Description |
xiv, 403 pages : illustrations (some color) ; 25 cm |
| Contents |
1. Analytical validation within the pharmaceutical environment / Joachim Ermer -- 2. Performance parameters, calculations and tests -- 3. Case study : validation of an HPLC-method for identity, assay, and related impurities / Gerd Kleinschmidt -- 4. Qualification of analytical equipment / David Rudd -- 5. Validation during drug product development - considerations as a function of the stage of drug development / Martin Bloch -- 6. Acceptance criteria and analytical variability / Hermann Watzig -- 7. Transfer of analytical procedures / Mark Broughton and Joachim Ermer -- 8. Validation of pharmacopoeial methods / John H. McB. Miller -- 9. Analytical procedures in a quality control environment / Raymond A. Cox -- 10. Aberrant or atypical results / Christopher Burgess -- 11. Future trends in analytical method validation / David Rudd |
| Summary |
"Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness." "With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities."--BOOK JACKET |
| Bibliography |
Includes bibliographical references and index |
| Subject |
Drugs -- Analysis.
|
|
Methodology -- Validity.
|
| Author |
Miller, John H. McB.
|
| ISBN |
9783527312559 cased |
|
3527312552 cased |
|
9783527312559 cased |
|
9783527312559 |
|
