Past Studies definition

Past Studies means, collectively, the following clinical studies that have been completed or terminated prior to the Effective Date: (a) “Clinical Trial to Test the Safety and Effectiveness of an Investigational Drug CHR-2797 With Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer”, NCT00522938 [Terminated–Poor Recruitment], (b) “Safety Study to Evaluate CHR-2797 in Patients With Advanced Tumours”, NCT00692354 [Completed], (c) “A Study of the Safety and Tolerability of the Addition of CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours”, NCT00737555 [Completed], and (d) “ A Phase I-II Study to Evaluate the Safety, Tolerability and Anti-Disease Activity of the Aminopeptidase Inhibitor, CHR-2797, in Elderly and/or Treatment Refractory Patients with Acute Myeloid Leukaemia or Multiple Myeloma”, NCT00689000 [Completed].
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Past Studies means, collectively, the following clinical studies that have been completed or terminated prior to the Effective Date: (a) “Clinical Trial to Test the Safety and Effectiveness of an Investigational Drug CHR-2797 With Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer”, NCT00522938 [Terminated–Poor Recruitment], (b) “Safety Study to Evaluate CHR-2797 in Patients With Advanced Tumours”, NCT00692354 [Completed], (c) “A Study of the Safety and Tolerability of the Addition of CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours”,
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Examples of Past Studies in a sentence

  • Within sixty (60) days after the Effective Date, Chroma shall make available to CTI copies of all Development Documentation that are Controlled by Chroma generated as of the Effective Date and relating to the use of the Product in the Field, including any drug master files and Regulatory Materials for the Past Studies.

Related to Past Studies

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

  • 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.

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • 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.

  • Interconnection Studies means the Interconnection Feasibility Study, the System Impact Study, and the Facilities Study described in Tariff, Part IV and Tariff, Part VI.