Bridging Clinical Study definition

Bridging Clinical Study means a human clinical study conducted [**] that is designed to demonstrate the [**] generated in a study of [**] treated with the Licensed Product to [**] of the Licensed Product in [**]. Data to evaluate in such a study might include pharmacokinetics, efficacy and/or additional safety data. The Bridging Clinical Study shall be designed such that, if its endpoints are met, [**], and to allow Kyowa Hakko [**] in seeking Regulatory Approval for the Licensed Product in Japan. It is expected that a Bridging Clinical Study shall require the enrollment of no more than [**] patients for the NDA submission in Japan. For purposes of clarity, if the Clinical Studies required by the Japanese Regulatory Authorities require more than [**] patients in total, those Clinical Studies shall be [**] and if the Clinical Studies required by the Japanese Regulatory Authorities require fewer than [**] patients in total, those Clinical Studies shall be [**].
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Related to Bridging Clinical Study

  • 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).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.