Phase 2/3 Clinical Trial definition

Phase 2/3 Clinical Trial means a human clinical trial of a Licensed Product that is not a Phase 2 Clinical Trial or a Phase 3 Clinical Trial, but some combination thereof.
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Phase 2/3 Clinical Trial shall have the meaning set forth in Section 4.1.3.
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Phase 2/3 Clinical Trial means, in reference to a clinical trial of a Licensed Product, a Phase 2 Clinical Trial involving a sufficient number of subjects that, prior to commencement of the trial or at any other defined point in the trial, satisfies both of the following ((a) and (b)):
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Examples of Phase 2/3 Clinical Trial in a sentence

  • Promptly after receipt of the Data and Safety Monitoring Committee’s recommendation regarding the continued conduct of the Pancreatic Cancer Phase 2/3 Clinical Trial after the ONTRAC Interim Analysis has occurred, Onconova shall notify Xxxxxx of such recommendation.

  • Adult and Pediatric Clinical Trial Data Phase 3 Clinical Trial n = 25,798 • Nov 2020 - Jan 2021 across 25 sites • Two doses, 28 days apart Phase 2/3 Clinical Trial in Children (2-18 years) • Observed GMTR = 1.32 (0.92, 1.90 [CI 95%]) n = 526 • May 2021 - Jul 2021 across 6 sites • Two doses, 28 days apart Source: Ella, Reddy, Blackwelder, Potdar, Yadav, Sarangi et al.

  • During the Term of this Agreement, Licensor shall (a) have Licensed Product Manufactured; and (b) sell and deliver to Avenue one hundred percent (100%) of the total requirements for Licensed Products in the Territory of Avenue, its Affiliates and Sublicensees for any Development activities after Phase 1b/2a Clinical Trial, including, Phase 2/3 Clinical Trial and Phase 3 Clinical Trial.


More Definitions of Phase 2/3 Clinical Trial

Phase 2/3 Clinical Trial means a human clinical trial involving a sufficient number of subjects that, prior to commencement of the trial or at any other defined point in the trial, satisfies both of the following ((i) and (ii)):
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Phase 2/3 Clinical Trial means either:
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Phase 2/3 Clinical Trial means a human clinical trial of a Product that is designed to evaluate both dosing requirements and the effectiveness of the Product for a particular indication in patients with the disease or condition under study and is consistent with the requirements of 21 C.F.R. §312.21(b) (as hereafter modified or amended) and 21 C.F.R. §312.21(c) (as hereafter modified or amended).
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Phase 2/3 Clinical Trial means a human clinical trial of a Product that is designed to evaluate both dosing requirements and the effectiveness of the Product for a particular indication in patients with the disease or condition under study and is consistent with
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Related to Phase 2/3 Clinical Trial

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Pivotal Clinical Trial means a clinical study of an investigational product in patients with the primary objective of confirming with statistical significance the efficacy and safety with the aim to obtain regulatory approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.