Phase II Study Initiation definition

Phase II Study Initiation means the first human clinical trial conducted in patients and designed to indicate a statistically significant level of efficacy for product in the desired indication, as well as to obtain some indication of the dosage regimen required; provided, however, with respect to oncology, "Phase II Study Initiation" means the first human clinical trial conducted on a series of patients with the same type and stage of cancer.
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Phase II Study Initiation means the first dose administered to the first patient in the first human clinical trial, whether in the United States or outside the United States, intended for submission to the FDA, or the applicable foreign Governmental Authority empowered to grant Regulatory Approval of a BLA, and designed to indicate a statistically significant level of efficacy for or a biomarker therefor for a product in the desired Indication, as well as to obtain some indication of the dosage regimen required.
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Phase II Study Initiation means the dosing of the first patient in the first human clinical trial conducted on a series of patients with the same type and stage of cancer.
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Examples of Phase II Study Initiation in a sentence

  • Phase II Study Initiation [***] Phase III Study Initiation [***] Regulatory Approval in US [***] Regulatory Approval in any of France, Germany, Italy, Spain or the UK [***] Each development event payment shall be paid only once the first time the first Product reaches the applicable Development event, regardless of the number of times such events are reached by the same or another Product.


More Definitions of Phase II Study Initiation

Phase II Study Initiation means the dosing of the first subject in the first human clinical trial, whether conducted in subjects in the United States or outside the United States, that falls within the definition of a “Phase 2” study in Section 312.21(b) of Title 21 of the U.S. Code of Federal Regulations, as amended from time to time, or the equivalent in any foreign country, and that is a controlled clinical study conducted to evaluate the effectiveness of the subject drug for the desired Indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.
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Phase II Study Initiation means the first human clinical trial conducted in patients and designed to indicate a statistically significant level of efficacy for product in the desired indication, as well as to obtain some indication of the dosage regimen required.
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Related to Phase II Study Initiation

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • 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 II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.