Method Validation in Pharmaceutical Analysis

Lingua: inglese

Editore: Wiley-VCH Verlag GmbH, DE, 2025

3527348905 / 9783527348909

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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. 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 qualificationAnalytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical proceduresMethod selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategyImplementation 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.…

Codice articolo LU-9783527348909

Titolo
Method Validation in Pharmaceutical Analysis
Autore
Joachim Ermer
Editore
Wiley-VCH Verlag GmbH, DE
Anno di pubblicazione
2025
Condizione
New
Rilegatura
Hardback
Lingua
inglese
ISBN 10
3527348905
ISBN 13
9783527348909
Edizione
terza edizione
Peso dell'articolo
680 grammi

Rarewaves.com USA

London, London, Regno Unito

Venditore con 5 stelle

Venditore AbeBooks dal 11 giugno 2025

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ArticoloDa 7 a 12 giorni lavorativiDa 7 a 12 giorni lavorativi
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