Phase 2b Clinical Trial means a study of a pharmaceutical product in human patients to determine efficacy and statistical trends prior to initiation of Phase 3 pivotal studies. These studies will also evaluate potential doses and dosing regimens to optimize the therapy under investigation.
Phase 2b Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial of the feasibility, safety, dose ranging and efficacy of such product, that is prospectively designed to generate sufficient data (if successful) to commence a Phase 3 Clinical Trial (or foreign equivalent) of such product, as further defined in 21 C.F.R. 312.21(b) or the corresponding regulation in jurisdictions other than the United States. A Phase 2B Clinical Trial shall be deemed initiated upon the dosing of the first patient.
Phase 2b Clinical Trial means a Phase 2 Clinical Trial that is designed in such a way as to provide efficacy and safety information about a Program Product that, alone or with other Phase 2b Clinical Trials, would be reasonably intended to lead to an End-of-Phase 2 (EOP2) meeting with the FDA, or an equivalent meeting with any Regulatory Health Authority, or a subsequent Phase 3 Clinical Trial, even if such EOP2 meeting or Phase 3 Clinical Trial does not occur.
Examples of Phase 2b Clinical Trial in a sentence
It is understood and agreed that ACS's review of data or its acceptance (or deemed acceptance) of Product pursuant to the provisions of this Article 6.1 shall in no way modify or diminish Biozyme's obligation hereunder.
Topical TrkA Kinase Inhibitor CT327 is an Effective, Novel Therapy for the Treatment of Pruritus due to Psoriasis: Results from Experimental Studies, and Efficacy and Safety of CT327 in a Phase 2b Clinical Trial in Patients with Psoriasis.
Based on these assessments, the Company identified one performance obligation at the outset of the Investment Agreement, which consists of: Phase 2b Clinical Trial research and development activities and related services.
For example, if Regulatory Approval for a Licensed Product is approved based on a Phase 2b Clinical Trial without a Phase 3 Clinical Trial, then upon Regulatory Approval, both the Regulatory Approval milestone and the initiation of a Phase 3 Clinical Trial milestone will be paid.
The attack surface comprises all possible avenues of attacking a system.
More Definitions of Phase 2b Clinical Trial
Phase 2b Clinical Trial means any Phase 2 Clinical Trial on sufficient numbers of patients that is designed to establish dosing parameters of the Licensed Product.
Phase 2b Clinical Trial means a human clinical trial performed in accordance with the Applicable Laws in patients with a particular disease or condition which is designed to assess the safety, dose ranging and efficacy of a pharmaceutical product to confirm clinical efficacy of a drug and determine the therapeutic dose range and may include such a clinical trial intended to be a Pivotal Trial. Any Phase 2 Clinical Trial of a Product in an indication that is the second Phase 2 Clinical Trial of such Product in such indication shall be deemed to be a Phase 2b Clinical Trial.
Phase 2b Clinical Trial means any human clinical trial conducted in the United States on a sufficient number of patients the primary purpose of which is to make a preliminary or qualitative determination of efficacy of a Product in the patients being studied for the dosage regimes indicated in the related Phase 2a Clinical Trial as required under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.
Phase 2b Clinical Trial means, with respect to a Product, any human clinical trial of such Product conducted in the United States on a sufficient number of patients the primary purpose of which is to make a preliminary or qualitative determination of efficacy of such Product in the patients being studied for the dosage regimes indicated in the related Phase 2a Clinical Trial as required under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.
Phase 2b Clinical Trial means, with respect to the United States, a clinical trial of a product, designed to support and precede the Initiation of a Phase 3 Clinical Trial program, on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such product in the target patient population over a range of doses and dose regimens, as described under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, an equivalent clinical trial.
Phase 2b Clinical Trial means a human clinical trial related to InsuLAR sponsored by Buyer, or one of its licensees, in any FDA or EMEA regulated country that would satisfy the requirements of 21 CFR 312.21(c) for a phase 2 clinical study.
Phase 2b Clinical Trial means, as to a particular Licensed Product for an Indication, a Phase 2 Clinical Trial, or the relevant portion thereof, conducted in a sufficient number of patients to generate sufficient data, if successful, to either commence a Phase 3 Clinical Trial of such Licensed Compound for such Indication or file an NDA for such Licensed Product for such Indication.