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Method Validation In Pharmaceutical Analysis A Guide To Best Practice 2nd Edition Joachim Ermer

  • SKU: BELL-4770096
Method Validation In Pharmaceutical Analysis A Guide To Best Practice 2nd Edition Joachim Ermer
$ 31.00 $ 45.00 (-31%)

5.0

58 reviews

Method Validation In Pharmaceutical Analysis A Guide To Best Practice 2nd Edition Joachim Ermer instant download after payment.

Publisher: Wiley-VCH
File Extension: PDF
File size: 4.37 MB
Pages: 440
Author: Joachim Ermer, Phil W. Nethercote
ISBN: 9783527335633, 3527335633
Language: English
Year: 2014
Edition: 2

Product desciption

Method Validation In Pharmaceutical Analysis A Guide To Best Practice 2nd Edition Joachim Ermer by Joachim Ermer, Phil W. Nethercote 9783527335633, 3527335633 instant download after payment.

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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