Isbn: 9783527348909 - method validation in pharmaceutical analysis: a guide to best practice (8 Ergebnisse)

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Buch. Zustand: Neu. Method Validation in Pharmaceutical Analysis | A Guide to Best Practice | Joachim Ermer (u. a.) | Buch | 544 S. | Englisch | 2026 | Wiley-VCH GmbH | EAN 9783527348909 | Verantwortliche Person für die EU: Wiley-VCH GmbH, Boschstr. 12, 69469 Weinheim, product-safety[at]wiley[dot]com | Anbieter: preigu. …

Buch. Zustand: Neu. Neuware - The third edition of this global standard guide for validated pharmaceutical analysis now incorporates the 2023 ICH guidelines Q2 and Q14, and new sections on data integrity and continuous monitoring.

Buch. Zustand: Neu. Neuware -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. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: - Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and 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 a 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, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities.Wiley-VCH GmbH, Boschstraße 12, 69469 Weinheim 544 pp. Englisch.…

Buch. Zustand: Neu. Neuware -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. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: - Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and 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 a 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, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities. 544 pp. Englisch.…