Phase III Clinical Studies definition

Phase III Clinical Studies means expanded and controlled human clinical studies involving administration of a drug to sufficient numbers of human patients with the goal of establishing that a drug is safe and efficacious for its intended use, and to be considered as a pivotal study for submission of an MAA, including, in the United States, a NDA or BLA as more fully defined in 21 C.F.R. §312.21(c) or its successor regulation, and including any such clinical study in any country other than the United States.
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Phase III Clinical Studies means controlled human clinical studies involving administration of a drug with the goal of establishing that a drug is safe and efficacious for its intended use, and to be considered as a pivotal study or studies for submission of an NDA.
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Phase III Clinical Studies means that portion of the clinical
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Examples of Phase III Clinical Studies in a sentence

  • After or near the conclusion of the Phase III Clinical Studies for the Xxxxx Indication, PFIZER and XXXXX will meet with the FDA in a Pre-NDA Meeting to discuss the results of such studies.

  • After reviewing the minutes of the EOP2 Meeting, if the Participating Phase IIb Party’s JDC representatives are of the view that such Product Candidate is ready for Phase III Clinical Studies, the Participating Phase IIb Party may proceed under Section 5.6(d).

  • If the JDC representatives of the Participating Phase IIb Party under a Unilateral Phase IIb Plan determine that further Clinical Studies or Non-Clinical Studies are required prior to advancing the applicable Product Candidate to Phase III Clinical Studies, then such Participating Phase IIb Party shall have the right to amend the Unilateral Phase IIb Plan to include such additional Development activities in accordance with Section 5.6(b)(iii).

  • If after completion of all Development activities under the applicable Joint Phase IIb Plan, either (or both) Party’s representatives on the applicable JDC are of the view that further Clinical Studies or Non-Clinical Studies are required prior to advancing the applicable Product Candidate under a Joint Phase IIb Plan to Phase III Clinical Studies, then [***].

  • At the conclusion of such additional Development activities, the Parties shall again assess the readiness for such Product Candidate for further Development in Phase III Clinical Studies in accordance with Sections 5.5(b)(vi), 5.5(b)(vii), and 5.5(b)(viii).

  • Promptly after its formation, the JDC for a particular Product Candidate shall review and discuss the Clinical Data and other data and results generated under the Exploratory Development Program for such Product Candidate and the likely timeline and path for Development of such Product Candidate through Phase III Clinical Studies.

  • After reviewing the minutes of the EOP2 Meeting, if both Parties’ JDC representatives agree that such Product Candidate is ready for Phase III Clinical Studies in the applicable Indication, the Parties shall proceed under Section 5.5(d).

  • If either Party’s representatives on the JDC are of the view that such Product Candidate is not ready for Phase III Clinical Studies, [***].

  • By way of example, as to each indication with respect to each Collaboration Compound or Licensed Product, MERRIMACK may be responsible, subject to MERRIMACK’s agreement and the JSC approval, for conducting a number of Phase III Clinical Studies or for providing diagnostic research support activities (e.g., model, algorithm, threshold refinements and related in vitro and in vivo research).

  • Phase III Clinical Studies and NDA/BLA filing shall be solely Genentech's obligation at Genentech's sole expense, the soleness of the expenses borne by Genentech being subject only to Magainin's opt-in for co-funding under Section 8.6 hereof.


More Definitions of Phase III Clinical Studies

Phase III Clinical Studies means a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in U.S. FDA 21 C.F.R. 312.21(c) or similar regulations in a Major Market Country;
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Phase III Clinical Studies means that portion of the clinical development program beyond Phase II, which provides for large scale clinical studies conducted in a sufficient number of patients to establish the clinical efficacy of a Product for one or more indications and its safety, as more fully defined in the United States in 21 C.F.R.Section 312.21(c).
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Phase III Clinical Studies means the type of studies defined in 21 C.F.R. 312.21(c) or any successor to such provision and the foreign equivalent thereof.
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Phase III Clinical Studies means that portion of the clinical 6 DEVELOPMENT PLAN or DEVELOPMENT WORK which provides for one or more large scale clinical studies conducted in a sufficient number of patients to establish a PRODUCT’s clinical efficacy and safety for one or more indications, as more fully defined in 21 C.F.R. 312.21(c).
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Related to Phase III Clinical Studies

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval 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 III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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 I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 IIb Clinical Trial means a clinical trial of a Product 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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 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 the JDC and that otherwise fit the foregoing definition.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Clinical Trial means any human clinical trial of a Product.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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:

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of 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. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.