Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). ICH guidelin...

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Bibliographic Details
Main Authors: N. V. V. S. S. Raman, Useni Reddy Mallu, Hanimi Reddy Bapatu
Format: Article
Language:English
Published: Wiley 2015-01-01
Series:Journal of Chemistry
Online Access:http://dx.doi.org/10.1155/2015/435129
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