The Delivery of Flexibility from the Application of QbD to API Development

Matt E. Popkin,Phil J. Borman,Batool Ahmed Omer,Kevin D. Seibert,Sushil Srivastava,John V. Lepore,Lindsay Hobson, John Donaubauer,Timothy Curran, Nathan Ide, Steven Tymonko,Adam Looker,Jeffrey M. Kallemeyn

Journal of pharmaceutical innovation（2018）

引用 5|浏览20

关键词

ICH,Control strategy,Quality by Design (QbD),Process,Methods,Models,CMC,Regulatory flexibility,Process analytical technology (PAT),Manufacturing process description,S2.2

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