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The regulatory framework anchored by FDAs 2003 BA/BE guidance and 2002 CMC guidance, and USP General Chapter defines precise measurement requirements, lifestage sampling protocols, and statistical approaches for both brand-name NDA and generic ANDA development programs

Psychopharmacology 233 , 17251737 (2016)

Each compound in such a custom protocol uses its own reconstitution concentration and dosing schedule

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