PATH STUDIES definition
PATH STUDIES. As defined in SECTION 1.1 of SCHEDULE A.
PATH STUDIES. As defined in Section 1.1 of Schedule A.
PATH STUDIES. As defined in SECTION 1.1
More Definitions of PATH STUDIES
PATH STUDIES. As defined in 1.1
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Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;
Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.