Method Validation in Pharmaceutical Analysis

Language: English

Published by Wiley-VCH Gmbh Apr 2025, 2025

3527348905 / 9783527348909

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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.…

Seller Inventory # 9783527348909

Title
Method Validation in Pharmaceutical Analysis
Author
Phil W. Nethercote
Publisher
Wiley-VCH Gmbh Apr 2025
Publication year
2025
Condition
Neu
Binding
Buch
Language
English
ISBN 10
3527348905
ISBN 13
9783527348909
Edition
3rd Edition
Item weight
1,180 grams
Dimensions
244x174x32 mm

Wegmann1855

Zwiesel, Germany

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