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Ermer, Joachim

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Ermer, Joachim - Method Validation in Pharmaceutical Analysis: A Guide to Best Practice, ebook

163,70€

Ebook, ePUB with Adobe DRM
ISBN: 9783527672189
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Printing144 pages with an additional page accrued every 6 hours, capped at 144 pages
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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.

Keywords: Drug QA/Analysis

Author(s)
 
Publisher
John Wiley and Sons, Inc.
Publication year
2015
Language
en
Edition
2
Page amount
480 pages
Category
Medicine, Health Care, Mode
Format
Ebook
eISBN (ePUB)
9783527672189
Printed ISBN
9783527335633

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