Method Validation in Pharmaceutical Analysis -

Method Validation in Pharmaceutical Analysis
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Wydawnictwo: VCH
ISBN: 9783527335633
EAN:
Format: ...
Oprawa: twarda
Stron: 440
Data wydania: 2014-10-01
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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.

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