BIOSTUDY definition

BIOSTUDY means a set of analytical studies, including pharmacokinetic (PK) studies, and clinical trials or other tests that are reasonably designed to meet FDA procedures and requirements for bioequivalence of an applicable product to the branded version thereof.
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BIOSTUDY means that certain study in connection with the Development of the Vasocard Product as more particularly described on Schedule 1.5.
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BIOSTUDY means a clinical blood-level study used to demonstrate bioequivalence as required by FDA Rules.
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Related to BIOSTUDY

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.