TY  - BOOK
AU  - Ermer,Joachim
AU  - Nethercote,Phil
TI  - Method validation in pharmaceutical analysis: a guide to best practice 
SN  - 9783527348909
U1  - 615.1901 
PY  - 2025///
CY  - Weinheim
PB  - Wiley-VCH
KW  - Drugs Analysis
KW  - Pharmaceutical chemistry
KW  - Chemical analysis
N1  - Index present
N2  - 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
ER  -