000			01602nam a22002537a 4500
005			20260921153427.0
008			260921s2025 |||||||| |||| 00| 0 eng d
020			_a9783527348909
040			_cPK-LaUMT
082			_a615.1901 _bMET-
245	0	0	_aMethod validation in pharmaceutical analysis : _ba guide to best practice / _cedited by Joachim Ermer and Phil Nethercote
250			_a3rd ed.
260			_aWeinheim : _bWiley-VCH, _c2025
300			_axviii, 521 p.
500			_aIndex present
520			_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.
546			_aEng
650			_aDrugs Analysis _915633
650			_aPharmaceutical chemistry _91301
650			_aChemical analysis _915634
700	1		_aErmer, Joachim _915635
700	1		_aNethercote, Phil _915636
942			_cBK
999			_c142598 _d142598