Preclinical Development definition

Preclinical Development means the conduct of studies of the Product, in vitro or in animals, to assess the pharmacokinetics and safety (i.e., toxicology, carcinogenicity and mutagenicity) of the Product.

Preclinical Development means all pre-clinical and non-clinical Development activities for a Candidate or Product undertaken prior to the commencement of the first Clinical Trial for such Candidate or Product, including non-clinical studies and other material Development activities to be undertaken to generate data sufficient to enable the filing of an IND.

Preclinical Development means the commencement of potency and efficacy testing of a compound in animal models.

Examples of Preclinical Development in a sentence

• Preclinical Development of Ipilimumab and Nivolumab Combination Immunotherapy: Mouse Tumor Models, In Vitro Functional Studies, and Cynomolgus Macaque Toxicology.

• If BMS has concerns regarding any specific scientist assigned to the Preclinical Development Program, such concerns shall be communicated to the JRC for its consideration.

• The purpose of the Preclinical Plan is to detail the responsibilities and activities of CytomX and BMS with respect to carrying out the Preclinical Development Program.

• For this reason, CIRM does not require that the PI who led the translational research to identify the Development Candidate also be the PI for the Preclinical Development project.

• If CytomX develops any assays, that are not Tools, used in the Preclinical Development Program, upon request by BMS, CytomX shall transfer to BMS the CytomX Materials and Information to enable BMS to use such assays in support of BMS’ research and development activities under this Agreement.

More Definitions of Preclinical Development

Preclinical Development means those preclinical studies with respect to the Compounds and/or Products that are specifically required for an IND, including without limitation ADME and GLP toxicology studies, or studies required for the CMC section of an IND or an NDA. It is understood that “preclinical” testing will continue after the filing of an IND in support of the clinical development of a Compound or Product, including ongoing toxicology, metabolic, PK and other non-clinical testing of such Compound or Product, and that “Preclinical Development” as used herein shall include such ongoing non-clinical testing.

Preclinical Development means any and all non-clinical Development activities performed by a Party until and including animal in vivo Proof of Concept Milestone.

Preclinical Development shall refer to all activities relating to the planning and execution of non-human studies conducted in IN VITRO or in relevant IN VIVO animal models directed toward obtaining Regulatory Approval of a Product in each regulatory jurisdiction in the Territory. This includes preclinical testing, pharmacokinetics, toxicology, documentary and medical writing directly related to Preclinical Development activities, and related regulatory affairs and outside counsel regulatory legal services.

Preclinical Development means those Development activities performed before the filing of an IND.

Preclinical Development means all activities relating to the planning and execution of non-human studies conducted in in vitro or in relevant in vivo animal models directed toward obtaining Approval of a Product in each regulatory jurisdiction in the Territory. This includes preclinical testing, pharmacokinetics, toxicology, documentary and medical writing directly related to Preclinical Development activities and related regulatory affairs.

Preclinical Development means any and all processes and activities for the discovery and research of Other Protein Variants and development of Other Compounds and associated Other Products including those processes and activities, whether in vitro or in vivo conducted to: (i) discover, screen, optimize, clone, express, purify, formulate, characterize or enhance any Other Compound, including synthesis or Shuffling of any Other Compound, conjugation thereof, or similar activities; (ii) perform IND Enabling Studies with respect to an Other Compound and (iii) discover, develop, optimize, characterize or enhance technologies and tools including assays, screens, biological models, software and databases reasonably for the support of or in connection with any of the activities described in clauses (i) and (ii) above or development or manufacture.

Preclinical Development means, with respect to a particular Program, any research, preclinical and process development activities relating to such particular Program, up to the delivery of a Final Report.