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Cover image for product 3527312552
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
ISBN: 978-3-527-31255-9
Hardcover
418 pages
May 2005
US $240.00 Add to Cart

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  • Description
  • Table of Contents
  • Author Information
  • Reviews
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.

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