Method Validation in Pharmaceutical Analysis, Gebunden
Method Validation in Pharmaceutical Analysis
- A Guide to Best Practice
- Herausgeber:
- Joachim Ermer, Phil W. Nethercote
- Verlag:
- Wiley-VCH GmbH, 04/2025
- Einband:
- Gebunden
- Sprache:
- Englisch
- ISBN-13:
- 9783527348909
- Artikelnummer:
- 11943542
- Umfang:
- 544 Seiten
- Nummer der Auflage:
- 25003
- Ausgabe:
- 3. Auflage
- Gewicht:
- 666 g
- Maße:
- 244 x 170 mm
- Stärke:
- 15 mm
- Erscheinungstermin:
- 2.4.2025
- Hinweis
-
Achtung: Artikel ist nicht in deutscher Sprache!
Klappentext
New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14
Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysisprovides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis.
This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance.
Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as:
- Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualification
- Analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures
- Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy
- Implementation of compendial / pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures
Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities.
Biografie (Joachim Ermer)
Joachim Ermer is Director of Analytical Processes and Technology in Quality Operations, Global Analytical Development of Aventis. He is responsible for supporting and advising the Quality Control sites in analytical aspects, including training. Before joining Hoechst in Frankfurt as Head of Laboratory in Pharma Quality Control Development Products in 1991, he obtained his PhD in biochemistry from University of Halle, Germany in 1988 and worked as research scientist and post-doc fellow at the Universities of Halle and Cambridge, UK. He has a broad experience in analytical activities in pharmaceutical development and quality control, such as method development, specification design, regulatory documentation, etc. His special interests are validation and related topics to achieve robust and reliable analytical procedures.
