Method Validation in Pharmaceutical Analysis —— A Guide to Best Practice

----- 药物分析中的方法验证

ISBN: 9783527672196 出版年：2006 页码：419 Joachim Ermer John H McB Miller Wiley

Preface.List of Contributors.Part I: Fundamentals of Validation in Pharmaceutical Analysis.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).Part II: Life-cycle Approach to Analytical Validation.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 (Section 7.3)).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).Index.