{"title":"Joachim Ermer","description":null,"products":[{"product_id":"method-validation-in-pharmaceutical-analysis-book-joachim-ermer-9783527348909","title":"Method Validation in Pharmaceutical Analysis","description":"New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2 and Q14   Following an all-encompassing lifecycle approach to analytical procedures in pharmaceutical analysis, 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 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.   Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis 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   Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis 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.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":51201493008657,"sku":"NGR9783527348909","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"GB \/ NEW \/ INGRAM","offer_id":53468850913553,"sku":"NLS9783527348909","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/3527348905.jpg?v=1751221314"},{"product_id":"method-validation-in-pharmaceutical-analysis-book-joachim-ermer-9783527335633","title":"Method Validation in Pharmaceutical Analysis","description":"This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing.    As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout.    The undisputed gold standard in the field.","brand":"WoB","offers":[{"title":"- \/ - \/ -","offer_id":51399419298065,"sku":"","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"GB \/ NEW \/ GARDNERS","offer_id":51399419429137,"sku":"NGR9783527335633","price":0.0,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/3527335633.jpg?v=1751064904"}],"url":"https:\/\/www.worldofbooks.com\/collections\/author-books-by-joachim-ermer.oembed","provider":"World of Books ","version":"1.0","type":"link"}