01518nam a22002297a 450000500170000000800410001702000180005804000130007608200190008924501240010825000120023226000330024430000180027750000180029552008570031354600080117065000190117865000290119765000220122670000190124870000210126720260921153427.0260921s2025    |||||||| |||| 00| 0 eng d  a9783527348909  cPK-LaUMT  a615.1901bMET-00aMethod validation in pharmaceutical analysis :ba guide to best practice /cedited by Joachim Ermer and Phil Nethercote  a3rd ed.  aWeinheim :bWiley-VCH,c2025  axviii, 521 p.  aIndex present  aNew 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.  aEng  aDrugs Analysis  aPharmaceutical chemistry  aChemical analysis1 aErmer, Joachim1 aNethercote, Phil