Clinical Development definition

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).

Examples of Clinical Development in a sentence

  • Discovery of 4- ((3'R,4'S,5'R)-6″-Chloro-4'-(3-chloro-2-fluorophenyl)-1'-ethyl-2″-oxodispiro[cyclohexane- 1,2'-pyrrolidine-3',3″-indoline]-5'-carboxamido)bicyclo[2.2.2]octane-1-carboxylic Acid (AA- 115/APG-115): A Potent and Orally Active Murine Double Minute 2 (MDM2) Inhibitor in Clinical Development.

  • The main objective with the use case is to confirm that the LarKC platform fulfil its requirement and develop value to Early Clinical Development trough semantic data integration and interpretation.

  • The “Requirements summary and data repository” deliverable presents requirements for the semantic data integration in Early Clinical Development use case and the first iteration of the data repository.

  • This section specifies the initial list of formal requirements towards Early Clinical Development use case prototype to be realized with the LarKC platform.

  • A Potent and Orally Active Antagonist (SM-406/AT-406) of Multiple Inhibitor of Apoptosis Proteins (IAPs) in Clinical Development for Cancer Treatment.

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 Research and Development after the fulfilment of Decision Point II.