Phase III Clinical definition

Phase III Clinical. Trial shall mean a pivotal multi-center human clinical trial in a large number of patients to establish safety or efficacy in the particular claim and indication tested and required to obtain Regulatory Approval.

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Phase III Clinical. Trial shall mean a clinical trial of a Licensed Product in human patients, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use, (b) to define warnings, precautions and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, (c) to be, either by itself or together with one or more other Clinical Trials having a comparable design and size, the final human Clinical Trial in support of Regulatory Approval of a Marketing Authorization of such Licensed Product, and (d) consistent with 21 U.S. CFR § 312.21(c).

Phase III Clinical. Trial shall mean a controlled, and usually multi-center, clinical trial, involving patients with the disease or condition of interest intended to obtain sufficient efficacy and safety data to support Marketing Approval of a candidate drug whether or not designated as “Phase III”, such as trials referred to in 21 C.F.R. §312.21(c) and foreign equivalents. Typical elements of a Phase III Clinical Trial are described in more detail in Section 3.1.3.3 of ICH Topic E8 (GENERAL CONSIDERATIONS FOR CLINICAL TRIALS).

Examples of Phase III Clinical in a sentence

Licensee will notify GenuPro in writing upon its first initiation of a Phase III Clinical Study in the Field involving a CTM Product within fourteen (14) days of such initiation.
At such time as Nuvios shall have successfully implemented and scaled-up the manufacturing processes so as to be capable of supplying adequate quantities of conforming Licensed Compound and Licensed Product for such Phase III Clinical Trial, Ipsen shall cease all manufacturing activities with respect to Licensed Compound and Licensed Product.
If ADCT elects a Withdrawal, then Genmab, if it elects to be the Continuing Party, shall be the sole developing Party and be solely responsible for executing and funding the Pre-Clinical Work Plan and Clinical Work Plan, as approved and modified by the JSC from time to time, until the completion of the Qualifying Phase I/II Clinical Trial.
Prior to the commencement of a Phase III Clinical Trial with respect to Licensed Compound or Licensed Product by Nuvios, Nuvios shall use reasonable commercial efforts to review and implement and scale-up the manufacturing processes in a timely manner so as to be capable of supplying adequate quantities of conforming Licensed Compound and Licensed Product for a Phase III Clinical Trial in compliance with the targeted timelines of the Development Plan and the Japanese Development Plan.
Not later than the commencement of Phase III Clinical Trials for any Product, BTC and Auxilium will establish a Joint Commercialization Committee (the “JCC”) made up of two (2) representatives designated by each Party hereto to assist in coordinating interactions and resolving potential disagreements between BTC and Auxilium during the course of the Commercialization of Product.

More Definitions of Phase III Clinical

Phase III Clinical. TRIALS shall have the meaning set forth in Section 6.1(b).

Phase III Clinical. Trial shall mean a clinical study in patients, conducted in accordance with a protocol approved by the Joint Operations Committee, which protocol is designed to ascertain efficacy and safety of a Product for the purpose of preparing and submitting a Registration Filing to the competent Regulatory Authority in a particular country in the Territory.

Phase III Clinical. Trial shall mean one or more controlled studies in humans of the efficacy and safety of an R&D Candidate, which is prospectively designed to demonstrate statistically whether the R&D Candidate is safe and ef- fective for use in a particular indication, in a manner intended to be sufficient to obtain Regulatory Approval to market that R&D Candidate and which the Joint Project Team designates as a Phase III Clinical Trial.

Phase III Clinical. Trial shall mean 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 equivalent legislation in the Licensed Territory. For clarity, the PROTECT Study and the DUPLEX Study are each a Phase III Clinical Trial hereunder.

Phase III Clinical. Trials” 5 1.38. “Preclinical Compound” 5 1.39. “Preclinical Development” 5 1.40. “Receiving Party” 5 1.41. “Research Period” 5 1.42. “Research Plan” 5 1.43. “Research Program” 6 1.44. “Royalty-Bearing Product” 6 1.45. “Royalty Period” 6 1.46. “Research Committee” 6 1.47. “Sublicensee” 6

Phase III Clinical. Trial or Pivotal Trial means (a) a controlled study of a Product in patients of the efficacy and safety of such Product which is prospectively designed to demonstrate statistically whether such Product is effective and safe for use in a particular indication in a manner sufficient to obtain Regulatory Approval to market such Product or (b) a clinical trial that the sponsoring Party or its Affiliate refers to in a press release as a Phase III Clinical Trial or Study.

Phase III Clinical. TRIALS means a series of expanded controlled and uncontrolled, pivotal, multi-center (generally) clinical studies, after adequate completion of preliminary efficacy and dose-ranging studies, and after safety data has been established for a GIT R&D PRODUCT, comprising patients with the disease or condition of interest, to whom the GIT R&D PRODUCT is administered in order to obtain sufficient efficacy and safety data (and better understand drug-related adverse effects) to support regulatory submissions and labeling of the GIT R&D PRODUCT.