Method validation in pharmaceutical analysis : a guide to best practice

• Other Authors: Ermer, Joachim, (Editor), Nethercote, Phil, (Editor)
• Format: eBook
• Language: English
• Published: Weinheim : Wiley-VCH, [2014]
• Edition: Second, completely revised and updated edition.
• Subjects: Drugs > Analysis.; Methodology > Validity.; elektronické knihy; electronic books
• ISBN: 9783527672196; 3527672192; 9783527672202; 3527672206; 9783527335633; 3527335633
• Physical Description: 1 online resource
• Access: Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty

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) regul.