Clinical Development definition

Clinical Development means the conduct of studies of the Product in humans in the Field to assess the dosing, safety and/or efficacy of the Product, including but not limited to Xxxxx 0 Clinical Trials, Phase 2 Clinical Trials and Phase 3 Clinical Trials, or as required by the applicable Regulatory Authority.
Clinical Development or “Clinically Develop” means all Development activities which are directed to the preparation for, conduct of, and analysis of a clinical trial or study of the Product, including, without limitation, as applicable, preclinical testing, toxicology, the examination of particular patient sub-populations within a given indication, and regulatory affairs which do not relate specifically to manufacturing of the Product (including preparation and submission of Regulatory Materials but excluding the Chemistry Manufacturing and Controls related portions of an such Regulatory Materials).
Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

Examples of Clinical Development in a sentence

  • Current and Future Analysis Targeted Therapy – An OverviewTargeted Therapy: The New Frontier of Cancer Treatment List of Select Approved Targeted Therapy Drugs by IndicationSelect Targeted Anti-Cancer Therapies in Late-Stage (Phase III) Clinical Development Table 7.

  • Cancer Causes in Developed and Developing Countries (2010): Percentage Breakdown by Risk Factors – Diet or Nutrition, Infections, Tobacco, and Other Factors (includes corresponding Graph/Chart) Types of Cancers Prostate CancerSelect FDA-Approved Prostate Cancer DrugsSelect Prostate Cancer Agents in Mid- & Late-Stage Clinical Development Table 12.

  • In addition, accounting, payroll, human resources and information technology services are provided to the Company through the GVI agreement.Clinical research services are provided through a consulting agreement with GVI Clinical Development Solutions ("GVI CDS"), a company controlled by the Chief Executive Officer.

  • Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM) BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden and AstraZeneca R&D, Gothenburg, SE-431 83 Corresponding Author: K.

  • The Steering Committee shall have the authority to generally guide, plan , monitor and, if needed, direct the Clinical Development Plan, settle disagreements between the Parties, monitoring the patent filing strategy in the Territory.

More Definitions of Clinical Development

Clinical Development means all activities required for MARKET APPROVAL of PRODUCT in the TERRITORY (including without limitation clinical trials and toxicology studies), as well as all clinical activities desirable for optimized marketing of PRODUCT in the TERRITORY (including without limitation phase IIIb and phase IV studies). This term does not include any activities necessary for manufacture and/or supply of PRODUCT;
Clinical Development means all Development activities in humans for a Candidate or Product undertaken from and after Initiation of the first Phase I Clinical Trial for such Candidate or Product, including conduct of each Clinical Trial.
Clinical Development means the conduct of studies of a medicinal product in human subjects in order to
Clinical Development means those pre-clinical and clinical activities, including post Regulatory Approval studies that are necessary or reasonably useful to obtain or maintain Regulatory Approval for a product for an indication, including testing in animals for purposes of obtaining or maintaining a Regulatory Approval.
Clinical Development means the development of clinical protocols, clinical evaluation site selection, clinical patient selection, and clinical trial management to support the preparation and filing of all applicable Regulatory Filings, and obtaining all necessary regulatory, reimbursement and pricing approvals in the United States with respect to a Developmental Product. [DELETED]
Clinical Development means activities related to the development obligations of a party in connection with clinical trials, with respect to a Ribozyme Product for a particular indication. [*] Confidential treatment requested
Clinical Development means, with respect to a Licensed Product or Combination Product, [***] as the case may be, [***].