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Method Validation in Pharmaceutical Analysis: A Guide to Best Practice by Joachim Ermer, Phil W. Nethercote (Hardcover, 2014)

About this product

About this product

Product Information

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples 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.

Product Identifiers

Publisher
Wiley-Vch Verlag Gmbh
ISBN-13
9783527335633
eBay Product ID (ePID)
208757447

Product Key Features

Subject Area
Chemical Engineering
Author
Joachim Ermer, Phil w. Nethercote
Publication Name
Method Validation in Pharmaceutical Analysis: a Guide to Best Practice
Format
Hardcover
Language
English
Publication Year
2014
Type
Textbook
Number of Pages
440 Pages

Dimensions

Item Height
253mm
Item Width
180mm
Item Weight
962g

Additional Product Features

Editor
Phil w. Nethercote, Joachim Ermer
Country/Region of Manufacture
Germany

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