a guide to best practice Ermer, Joachim Nethercote, Phil text Weinheim Wiley-VCH 2025 3rd ed. monographic eng

print

xviii, 521 p. 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 Analysis provides 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. edited by Joachim Ermer and Phil Nethercote Index present Eng Drugs Analysis Pharmaceutical chemistry Chemical analysis 615.1901 MET- 9783527348909 260921 20260921153427.0