Validation of analytical methods : Approaches, criteria and accuracy profile Reference manual for pharmaceutical and analytical sciences

Language: English

Published by Our Knowledge Publishing, 2026

6630015061 / 9786630015065

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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nach der Bestellung gedruckt Neuware - Printed after ordering - This guide offers a rigorous, up-to-date exploration of a discipline at the heart of the analytical sciences. It begins with a critical overview of the main international standards in force - ICH Q2(R2), ICH Q14, ICH M10, FDA, EMA, SFSTP, Eurachem, IUPAC, COFRAC, AOAC and SANTE - analyzing for each the criteria adopted, the recommended experimental designs, the strengths and limitations. It then examines, with the rigorous terminology required by the International Vocabulary of Metrology, all the validation criteria: specificity, selectivity, linearity, precision, accuracy, limits of quantification and detection, robustness. Finally, it presents the accuracy profile, an integrated decision-making tool based on the concept of total error and beta-expectation tolerance intervals, which for the first time makes it possible to assess all sources of error simultaneously and globally across the entire analytical field - and to derive a clear, visual validation decision that can be defended before any regulatory authority.…

Seller Inventory # 9786630015065

Title
Validation of analytical methods : Approaches, criteria and accuracy profile Reference manual for pharmaceutical and analytical sciences
Author
Faiza Bouchala
Publisher
Our Knowledge Publishing
Publication year
2026
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
6630015061
ISBN 13
9786630015065
Item weight
96 grams
Dimensions
220x150x4 mm

AHA-BUCH GmbH

Einbeck, Germany

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AbeBooks seller since August 14, 2006

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