Phase III Studies definition

Phase III Studies means large, adequate and well-controlled clinical studies that are conducted in human patients, after successful completion of the first Phase II Study, designed to evaluate safety and therapeutic efficacy of the Product and that are needed to obtain regulatory approval(s) and product labeling, with respect to (i) the United States, as more fully defined in 21 C.F.R. § 312.21(c), as may be amended; or (ii) the equivalent of such a clinical study for submission to the EMEA; or (iii) equivalent submission in such other country or jurisdiction.

Phase III Studies means that portion of the clinical U.S. ----------------- Development Plan, ROW Development Plan or Development relating to each Collaboration Product which provides for large scale, pivotal, clinical studies conducted in a sufficient number of patients and whose primary objective is to obtain a definitive evaluation of the therapeutic efficacy and safety of the Collaboration Product in patients for the particular indication in question that is needed to evaluate the overall risk-benefit relationship of Collaboration Product and to provide adequate basis for obtaining requisite regulatory approval(s) and product labeling, as more fully defined in 21 C.F.R. (S) 312.21(c).

Phase III Studies means large scale clinical studies conducted in a sufficient number of patients to establish the Product clinical efficacy in the Field and its safety.

Examples of Phase III Studies in a sentence

• The Differential Efficacy of Pemetrexed According to NSCLC Histology: A Review of Two Phase III Studies.

• NRG-HN001: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA).

• Subcomponent 2.3: Preparation of Phase III Studies: Feasibility studies and detailed designs for Upper Deraniyagala Reservoir, RAP and EIA, bidding documents (US$7 million):This sub-component will finance feasibility studies, investigations and detailed designs, biodiversity surveys, environmental impact assessments of the proposed Upper Deraniyagala reservoir, and consultations, miscellaneous surveys and studies necessary for the construction of the reservoir to be undertaken in Phase III.

• This strengthening of joint operations within the pillar will also make it possible for the banks to support large financing transactions and foreign business op- erations, despite the fact that the banking struc- ture will be more decentralised than it is today.

• According to the National Institute of Health and Care Excellency (NICE) (34), atypical antipsychotic drugs mainly clozapine is preferred when response to first line antipsychotic therapy is lacking.

More Definitions of Phase III Studies

Phase III Studies means that portion of the Development Plan or Development relating to each Alliance Product which provides for large scale, pivotal, clinical studies conducted in a sufficient number of patients and whose primary objective is to obtain a definitive evaluation of the therapeutic efficacy and safety of the Alliance Product in patients for the particular indication in question that is needed to evaluate the overall risk-benefit profile of the Alliance Product and to provide adequate basis for obtaining requisite regulatory approval(s) and product labeling.

Phase III Studies means a series of controlled pivotal clinical trials, after completion of preliminary efficacy and dose-ranging studies and after adequate safety data has been established for a Product, that are necessary to obtain sufficient confirmatory efficacy and safety data for the preparation and submission of an NDA for such Product for the human therapeutic indication being investigated by the trials, and which are planned to involve a sufficient number of patients who suffer from the condition for which the NDA is to be submitted for submission of such NDA.

Phase III Studies means that portion of the clinical development program which provides for large scale clinical studies conducted in a sufficient number of patients to establish Product clinical efficacy for one or more indications and its safety, as more fully defined in 21 C.F.R. § 312.21(c).

Phase III Studies means the human clinical trials of the Product described in the Development Plan that are designed to ascertain efficacy and safety of the Product, for the purpose of enabling the preparation and submission of a NDA or a foreign equivalent thereof in the Territory.

Phase III Studies means clinical or other studies of any Agent which are necessary for approval of the applicable NDA.

Phase III Studies means a program of clinical studies approved by the FDA or other equivalent national or supranational regulatory agencies outside of the United States which, if successfully completed to the satisfaction of the FDA or equivalent agencies outside of the United States, is intended to enable the sponsor of the studies to file an NDA and/or other equivalent applications for Regulatory Approval (as defined below).

Phase III Studies means large, adequate and well controlled clinical studies that are conducted in human patients designed to demonstrate definitive information about safety and efficacy of the Licensed Product that is needed to evaluate the overall benefit-risk relationship with the primary objective being to obtain regulatory approval(s) and product labeling, as described in 21 C.F.R. § 312.12(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States. These studies and the approach are generally discussed with applicable Regulatory Authorities prior to initiation, but Regulatory Authority approval is not required prior to initiation of such studies.