Method validation in pharmaceutical analysis : a guide to best practice / edited by Joachim Ermer and Phil Nethercote

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TextPublication details: Weinheim : Wiley-VCH, 2025Edition: 3rd edDescription: xviii, 521 pISBN:

9783527348909

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DDC classification:

615.1901 MET-

Summary: 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.

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Books

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Current library	Call number	Copy number	Status	Barcode
UMT Health Sciences Campus	615.1901 MET- (Browse shelf(Opens below))		Available	154511
UMT Main Campus	615.1901 MET- (Browse shelf(Opens below))	C.2	Available	154512

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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.

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