01602nam a22002537a 4500 20260921153427.0 260921s2025 |||||||| |||| 00| 0 eng d 9783527348909 PK-LaUMT 615.1901 MET- Method validation in pharmaceutical analysis : a guide to best practice / edited by Joachim Ermer and Phil Nethercote 3rd ed. Weinheim : Wiley-VCH, 2025 xviii, 521 p. Index present 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. Eng Drugs Analysis 15633 Pharmaceutical chemistry 1301 Chemical analysis 15634 Ermer, Joachim 15635 Nethercote, Phil 15636 BK 142598 142598 0 0 0 0 HSC HSC 2026-09-21 0 615.1901 MET- 154511 2026-09-21 15:34:00 2026-09-21 BK 0 0 0 0 01 01 2026-09-21 0 615.1901 MET- 154512 2026-09-21 15:35:11 C.2 2026-09-21 BK