{"product_id":"method-validation-in-pharmaceutical-analysis-a-guide-to-best-practice-9783527348909","title":"Method Validation in Pharmaceutical Analysis: A Guide to Best Practice","description":"\u003cp\u003e • Author(s): Joachim Ermer\u003cbr\u003e • Publisher: Wiley-Vch\u003cbr\u003e • Publisher Imprint: Wiley-Vch\u003cbr\u003e • BISAC: Pharmacology\u003c\/p\u003e\u003cp\u003e\u003c\/p\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 and Q14\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eFollowing an all-encompassing lifecycle approach to analytical procedures in pharmaceutical analysis, \u003ci\u003eMethod Validation in Pharmaceutical Analysis\u003c\/i\u003e provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. \u003c\/p\u003e\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 Validation \u0026amp; Verification Expert Panel on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses trending topics in the field such as data integrity and continuous monitoring of analytical performance. \u003c\/p\u003e\u003cp\u003eWritten by a team of highly qualified pharmaceutical professionals, \u003ci\u003eMethod Validation in Pharmaceutical Analysis\u003c\/i\u003e includes information on sample topics such as:  *Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle *Continued HPLC performance qualification, analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures *Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy *Implementation of compendial\/pharmacopeia test procedures, transfer of analytical procedures, and the lifecycle approach to transfer of analytical procedures  \u003c\/p\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, QA officers, and public authorities tasked with relevant regulatory responsibilities.\u003c\/p\u003e","brand":"Wiley-Vch","offers":[{"title":"Hardcover","offer_id":45202307547287,"sku":"9783527348909","price":15664.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9783527348909.webp?v=1769208170","url":"https:\/\/atlanticbooks.com\/products\/method-validation-in-pharmaceutical-analysis-a-guide-to-best-practice-9783527348909","provider":"Atlantic Books","version":"1.0","type":"link"}