 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
This price is valid for United States. Change location to view local pricing and availability. |
An online version of this product is available through our subscription-based content service. Visit Wiley InterScience now |
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.
Buy Both and Save 20%!
 |
+ |  |
Buy Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
(List Price: US $240.00)
with More Practical Problem Solving in HPLC (List Price = US $90.00) Cannot be combined with any other offers. Learn more. |
