Clinical Development definition

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.

Clinical Development means all clinical development activities relating to obtaining Regulatory Approval to market and sell Licensed Product for a particular indication, dose or formulation (but not including post-Regulatory Approval activities required by the relevant regulatory authority to support such Regulatory Approval in a country or other post-approval product support clinical trials undertaken by the Parties, including any Phase IV Trials).

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.

Examples of Clinical Development in a sentence

• 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.

• 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.

• 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.

• As described in note 9(a), the business administration services summarized above are provided to the Company through a consulting agreement with GVI.Clinical research services are provided through a consulting agreement with GVI Clinical Development Solutions Inc.

• As described in note 10(a), the business administration services summarized above are provided to the Company through a consulting agreement with GVI.Clinical research services are provided through a consulting agreement with GVI Clinical Development Solutions Inc.

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 the conduct of studies of a medicinal product in human subjects in order to—

Clinical Development means the trials conducted in human subjects to determine the safety, efficacy and pharmacokinetics of a compound as required by the US FDA. Clinical Development includes Phase I, Phase II, Phase III (and IV if required), and the New Drug Application (NDA) for Regulatory Approval by the FDA .

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 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 any and all Development activities to be conducted in humans related to or in furtherance of Regulatory Approval, including all clinical trials and any such post-approval regulatory commitments, or Post-Approval Clinical Trials. The Clinical Development activities to be performed as part of the Collaboration shall be as described in the applicable Product Work Plan.

Clinical Development means any and all Development activities performed by a Party following the achievement of animal in vivo proof of concept Milestone.