Method Validation in Pharmaceutical Analysis - 9783527335633
Un libro in lingua di Ermer Joachim (EDT) Nethercote Phil (EDT) edito da Vch Pub, 2014
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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.
Informazioni bibliografiche
- Titolo del Libro in lingua: Method Validation in Pharmaceutical Analysis
- Sottotitolo: A Guide to Best Practice
- Lingua: English
- Autori : Ermer Joachim (EDT) Nethercote Phil (EDT)
- Editore: Vch Pub
- Collana: Vch Pub (Hardcover)
- Data di Pubblicazione: 10 Novembre '14
- Genere: MEDICAL
- Pagine: 418
- Dimensioni mm: 241 x 170 x 170
- EAN-13: 9783527335633