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Method Validation in Pharmaceutical Analysis 2e A Guide to Best Practice

Language EnglishEnglish
Book Hardback
Book Method Validation in Pharmaceutical Analysis 2e A Guide to Best Practice Joachim Ermer
Libristo code: 02645403
Publishers Wiley-VCH Verlag GmbH, October 2014
This second edition of a global best-seller has been completely redesigned and extensively rewritten... Full description
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This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. §As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies 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.

About the book

Full name Method Validation in Pharmaceutical Analysis 2e A Guide to Best Practice
Language English
Binding Book - Hardback
Date of issue 2014
Number of pages 440
EAN 9783527335633
ISBN 3527335633
Libristo code 02645403
Weight 968
Dimensions 236 x 316 x 22
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