PAT Applied in Biopharmaceutical Process Development And Manufacturing —— An Enabling Tool for Quality-by-Design

----- 生物制药工艺开发和制造中Pat应用

ISBN: 9781439829455 出版年：2011 页码：320 CRC Press

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 rapid growth in the biopharmaceutical area and the comp