Supplemental Study definition

Supplemental Study is any Clinical Study (other than any Post-Marketing Study) for an additional indication or other label expansion for a Licensed Product beyond the initial Indication contemplated by the Development Plan.
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Supplemental Study means any clinical study (other than any Post-Marketing Study) for an additional indication or other label expansion for a Licensed Product beyond what is contemplated in the then-current Development Plan or the Global Development Plan, as applicable, or any health economic and outcomes research studies, in each case, as and to the extent approved by the JSC.
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Supplemental Study has the meaning set forth in Section 3.5(a).
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Examples of Supplemental Study in a sentence

  • You are required to enroll in Supplemental Study Abroad Insurance (Futaikaigaku) to participate in the program.

  • Where a patient undergoing an ongoing course of care (including drug therapy), whether administered at home or on NHS premises, changes his/her home address the responsible commissioner will be determined by the patient’s ordinary residence when the course began until a trigger date is reached.

  • Such an audit resulted in a lowering of the Parson’s Transportation Group, Inc.

  • The distribution of matrix spike recovery data from the Information Collection Rule Supplemental Study is presented in Table 5 of EPA Method 1623.

  • Eligibility The LCI Supplemental Study program is open for funding to all communities that have completed an LCI study or have been grandfathered by ARC as completing an LCI equivalent study.

  • More specifically, the Department does not have sufficient confidence in the method and modeling used in the Supplemental Study to rely on it in evaluating the cost effectiveness of the proposed Three-Year Plans.

  • Supplemental Study The Department has identified multiple issues with the Supplemental Study.

  • The Supplemental Study consultant testified that “each one of these strategies lives within a set of.

  • First, the modeling in the Supplemental Study is not consistent with the study’s assumptions.

  • Acadia argues that the Supplemental Study appropriately accounts for GWSA compliance costs and, therefore, Acadia favors inclusion of the Supplemental Study results in assessing cost effectiveness (Acadia Brief at 7-9, 22).

Related to Supplemental Study

  • Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

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

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • 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.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • 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 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • 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.

  • 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.

  • Development Plan has the meaning set forth in Section 3.2.

  • 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 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 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase 3 Study means a clinical study of an investigational product in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Marketing 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 investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 3 Study shall be deemed commenced when Initiated.