Phase II Clinical Study definition

Phase II Clinical Study means, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Licensed Product for such indication.
Phase II Clinical Study means (a) a preliminary efficacy and safety human clinical study in any country conducted to evaluate a drug for a particular indication or indications in patients with the disease or condition under study, where at least one of the primary endpoints of such study is an efficacy endpoint, or (b) any human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(b) in the United States.
Phase II Clinical Study means a study of a Licensed Product in human patients to determine initial efficacy and dose range finding before embarking on Phase III Clinical Studies.

Examples of Phase II Clinical Study in a sentence

The Section 7.1 Notice for Licensed Products cannot be made to JPPLP prior to the end of the first Phase II Clinical Study for such Licensed Product.

Spline-interpolated partial frequency distributions of electrical distances from two sessions of dataset A32, one with 6 bridged electrodes (same session as used in Fig.

For other Licensed Products, the Section 5.1 Notice cannot be made to JJCC prior to the end of the first Phase II Clinical Study for such Licensed Product.

Conduct studies that are required to support Phase II Clinical Study(ies) as well as commence Phase II Clinical Study for brain tumors within the Territory within six months after SFDA endorses the study report for the Phase I Clinical Study and approves the commencement of Phase II Study; Portions of this exhibit have been omitted pursuant to a request for confidential treatment.

Phase II Data” means the final study report for the Day 57 period for a Phase II Clinical Study [*].


More Definitions of Phase II Clinical Study

Phase II Clinical Study means, as to a particular Licensed Product (a) for an oncology product, a clinical study in humans that is intended to obtain information on the Licensed Product’s activity for an Indication at a prescribed (or otherwise limited) dose and administration schedule, as well as additional information on the Licensed Product’s safety and toxicity, or (b) for a non-oncology product, a dose ranging clinical study in humans to evaluate further the efficacy and safety of the Licensed Product in the targeted patient population and to define the optimal dosing regimen. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase II Clinical Study” hereunder if such study has been designated by the sponsor as a Phase II clinical trial on www.clinicaltrials.gov (or any successor website maintained by the U.S. National Institutes of Health (or any successor agency of the U.S. Government)).
Phase II Clinical Study means a study of a Licensed Product in human patients to determine the safe and effective dose range in a proposed therapeutic indication as and to the extent defined for the United States in 21 C.F.R. § 312.21(b), or its successor regulation, or the equivalent regulation in any other country.
Phase II Clinical Study means (a) in connection with obtaining Marketing Authorization Approval in the United States, a Clinical Study in human patients, the primary intention of which is to collect data on dosages and demonstrate clinical safety and efficacy of a Licensed Product in a target population for a specific disease or condition under study, as more fully defined in 21 C.F.R. § 312.21(b), as may be amended or (b) in connection with obtaining Marketing Authorization Approval in any other jurisdiction, the equivalent of any such Clinical Study in such other country or jurisdiction.
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 Study means a Clinical Study of a Licensed Product that meets the definition of a Phase II study in the Clinical Trial Regulation EU No 536/2014 and for the United States as described in 21 C.F.R. §312.21(b), or its successor regulation, or the equivalent regulation in any other country.
Phase II Clinical Study means a study of a Product in human patients for which the primary endpoint is a preliminary determination of efficacy in patients being studied (for example, as described in 21 C.F.R. §312.21(b), or similar clinical study in a country other than the United States of America). A first-in-human study or any study for which a primary endpoint is directed to safety shall not be considered a Phase II Clinical Study.