{"product_id":"9783527348909-method-validation-in-pharmaceutical-ana","title":"Method Validation in Pharmaceutical Analysis","description":"\u003cmeta content=\"text\/html; charset=utf-8\" http-equiv=\"Content-Type\"\u003e\u003cp\u003e\u003cspan\u003eA Guide to Best Practice\u003cbr\u003e\u003cp\u003e\u003cb\u003eNew edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14\u003c\/b\u003e \u003c\/p\u003e\n\u003cp\u003eFollowing a holistic lifecycle approach to analytical procedures, \u003ci\u003eMethod Validation in Pharmaceutical Analysis \u003c\/i\u003eprovides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. \u003c\/p\u003e\n\u003cp\u003eThis 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. \u003c\/p\u003e\n\u003cp\u003eWritten by a team of highly qualified pharmaceutical professionals, \u003ci\u003eMethod Validation in Pharmaceutical Analysis\u003c\/i\u003e includes information on relevant topics such as: \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eData governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualification\u003c\/li\u003e\n\u003cli\u003eAnalytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures\u003c\/li\u003e\n\u003cli\u003eMethod selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy\u003c\/li\u003e\n\u003cli\u003eImplementation of compendial\/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eCompletely comprehensive in coverage, \u003ci\u003eMethod Validation in Pharmaceutical Analysis\u003c\/i\u003e is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities.\u003c\/p\u003e\n\u003cbr\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"Rarewaves","offers":[{"title":"Default Title","offer_id":55507506200950,"sku":"9783527348909","price":171.71,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0092\/7504\/8033\/files\/orig_41052450.jpg?v=1777280005","url":"https:\/\/www.rarewaves.com\/products\/9783527348909-method-validation-in-pharmaceutical-ana","provider":"Rarewaves.com","version":"1.0","type":"link"}