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  1. PAT Applied in Biopharmaceutical Process Development And Manufacturing

    An Enabling Tool for Quality-by-Design

    Edited by Cenk Undey, Duncan Low, Jose C. Menezes, Mel Koch

    Series: Biotechnology and Bioprocessing

    As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the...

    Published December 6th 2011 by CRC Press

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