Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products

The US FDA's rule on "Requirements for Submission of Bioequivalence Data" requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January 2009. With the publication of thi...

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Hoofdauteurs: Paramjeet Kaur (Auteur), Xiaojian Jiang (Auteur), Ethan Stier (Auteur)
Formaat: Boek
Gepubliceerd in: Frontiers Media S.A., 2017-07-01T00:00:00Z.
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