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.

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

• Impact of Precision Medicine in Diverse Cancers: A Meta-Analysis of Phase II Clinical Trials.

• Phase I and Phase II Clinical Trials generally require only a Plan.

• Until the earlier of (i) the completion of the Development Plan, or (ii) the grant of a Sublicense hereunder, BioLine shall not acquire or continue developing any projects in the fields of non-Hodgkins lymphomas and/or acute myeloid leukemia, except that BioLine may acquire and continue developing any such projects until the commencement of Phase II Clinical Trials for such projects (or any earlier stage).

• As part of this Agreement, the IND from for the folate receptor alpha Phase I trial was transferred from Mayo to TapImmune for amendment for the Company’s Phase II Clinical Trials on our lead product.

• Impact of Precision Medicine in Diverse Cancers: A Meta- Analysis of Phase II Clinical Trials.

More Definitions of Phase II Clinical Trials

Phase II Clinical Trials means a human clinical trial of a compound or product for an indication, the principal purpose of which is a determination of safety and efficacy for such indication in the target patient population as described in 21 C.F.R. §312.21(b), or similar clinical trial in a country other than the US.

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 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 against HBV.

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 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.