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）

Cited 5|Views20

Key words

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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