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Více informací o knize Method Validation in Pharmaceutical Analysis 2e A Guide to Best Practice

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Anotace knihy

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.

Parametry knihy

Zařazení knihy Knihy v angličtině Technology, engineering, agriculture Industrial chemistry & manufacturing technologies Industrial chemistry

• Plný název: Method Validation in Pharmaceutical Analysis 2e A Guide to Best Practice
• Autor: Joachim Ermer, Phil W. Nethercote
• Jazyk: Angličtina
• Vazba: Pevná
• Počet stran: 440
• EAN: 9783527335633
• ISBN: 3527335633
• ID: 02645403
• Nakladatelství: Wiley-VCH Verlag GmbH
• Hmotnost: 968 g
• Rozměry: 316 × 236 × 22 mm
• Datum vydání: 01. October 2014

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