Method Validation in Pharmaceutical Analysis
By: and
Sign Up Now!
Already a Member? Log In
You must be logged into Bookshare to access this title.
Learn about membership options,
or view our freely available titles.
- Synopsis
- 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.
- Copyright:
- 2015
Book Details
- Book Quality:
- Publisher Quality
- ISBN-13:
- 9783527672189
- Related ISBNs:
- 9783527335633
- Publisher:
- Wiley
- Date of Addition:
- 01/29/15
- Copyrighted By:
- Wiley
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Medicine
- Submitted By:
- N/A
- Usage Restrictions:
- This is a copyrighted book.