Approaches of formulation bridging in support of orally administered drug product development

Author:

Han Murui,Xu Jin,Lin Yiqing

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference159 articles.

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4. Administration, U.F.a.D., 1997b. Guidance for Industry. SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER).

5. Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations;Administration, U.F.a.D.,,2014

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