Phase II Clinical Trials definition

Phase II Clinical Trials means human clinical trials conducted to achieve a level of efficacy and safety of Product as well as a preliminary dosage in the particular indication tested.

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Phase II Clinical Trials means a Clinical Trial for the Product on a number of patients, no fewer than the number required to allow for the detection of statistical differences between the control and treated patients, for the purposes of determining dose and evaluating safety and efficacy in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

Phase II Clinical Trials means the initial clinical testing of a Compound in humans who are patients with a disease for which the Compound is being tested with the intention of gaining a preliminary assessment of the safety, efficacy and dosing regimen of a Compound in treating such disease.

Examples of Phase II Clinical Trials in a sentence

Except as otherwise agreed by the JSC, Ipsen shall make and supply, or cause to be made and supplied, all necessary clinical supply of the injection formulation of the Licensed Compound and/or Licensed Product (described in Appendix D hereto) that is available to Ipsen on the Effective Date for use by Nuvios for the performance of Phase I and first Phase II Clinical Trials under the Development Plan.
This Agreement shall expire upon completion of the Phase II Clinical Trials contemplated under this Agreement, unless extended by mutual agreement of the Parties.
Upon Genentech’s written request, and in any event within thirty (30) days following completion of Phase II Clinical Trials of a Curis Product, Curis shall provide Genentech with written documentation of the Curis Expenses incurred by Curis with respect to such Curis Product.
Prior to the end of Phase II Clinical Trials of each Franchise Product in the Co-Promotion Territory and subject to the applicable publication provisions of any Clinical Trial Agreements with investigators, the JDC with appropriate input from the JCC will determine the overall strategy for publication in support of such Franchise Product in the Co-Promotion Territory.
Jazz may disband the Joint Steering Committee at any time if (i) all Work Plans are completed or terminated, (ii) Codiak has completed its obligations to conduct Phase I Clinical Trials, Phase I/II Clinical Trials, and Phase II Clinical Trials, (iii) Codiak has not exercised its Development and Commercialization Options and has no further right to exercise such an option and (iv) the Manufacturing of all Licensed Products has been transferred to Jazz or its Affiliates.

More Definitions of Phase II Clinical Trials

Phase II Clinical Trials means investigational use of a Licensed Product for examining the suspected indication(s) and to determine potential short-term side effects in humans, under 21 C.F.R. Part 312 or comparable laws, rules, or regulations of another Regulatory Authority.

Phase II Clinical Trials means those clinical trials on sufficient numbers of patients that are designed to establish the safety and preliminary efficacy of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed and that satisfy the requirements of 21 CFR 312.21(b) (or its successor regulation), or an equivalent foreign clinical trial.

Phase II Clinical Trials means human clinical trials conducted in patients anywhere in the world in accordance with good clinical practice to demonstrate efficacy with the Product in the particular indication tested, as well as to obtain a preliminary indication of the limit and/or daily dosage regimen required.

Phase II Clinical Trials means any human clinical trials for which a Primary Endpoint is a preliminary determination of safety, biological activity, efficacy or dose ranges of a Shared Product or Independent Product, as the case may be, in patients with the disease target being studied as required by the relevant Regulatory Authorities.

Phase II Clinical Trials means those well-controlled clinical trials sponsored by Triangle, the primary objective of which (as reasonably determined by Triangle) is to ascertain additional data regarding the safety and tolerance of a Licensed Product and preliminary data regarding such Licensed Product's antiviral effects.

Phase II Clinical Trials means those clinical trials as defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the U.S.

Phase II Clinical Trials means well-controlled human clinical trials conducted in a relatively small number of patients (usually no more than several hundred) to collect preliminary data regarding its efficacy in the particular indication tested, as well as to obtain some indication of the dosage regimen required.