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 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.

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.

• Discovery of GSK2656157: An Optimized PERK Inhibitor Selected for Preclinical Development.

• In order to ensure effective leadership of this development stage program, an investigator may participate as a PI or a Co-PI on no more than two active CIRM Preclinical Development, Disease Team, Disease Team Therapy Development, Strategic Partnership, or Early Translational Development Candidate awards as of the funding start date for a Preclinical Development Award I.

• The purpose of the CIRM Preclinical Development Awards initiative is to fund early preclinical development activities for Development Candidates (DCs) derived from or targeting stem cells that have compelling and reproducible efficacy in preclinical models of disease or injury, and that are sufficiently well characterized to be ready for the transition from preclinical research to preclinical development.

• However, CIRM does expect that the research project PI will be part of the Preclinical Development project team.

More Definitions of Preclinical Development

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 Regulatory Approval of a Product in each 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 non-clinical Development activities performed by a Party until and including animal in vivo Proof of Concept Milestone.

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

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

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 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 drug development activities conducted by the Parties from the nomination by the JRC of a Safety Assessment Candidate for Preclinical Development, and up to but not including filing of an IND.