Non-Clinical Studies definition

Non-Clinical Studies means all non-human studies of Products.

Non-Clinical Studies means in vivo animal or in vitro pharmacology, pharmacokinetic, or toxicology testing.

Non-Clinical Studies means in vivo or in vitro experiments in which test

Examples of Non-Clinical Studies in a sentence

• NCI will ensure that Clinical Studies must be conducted by Approved Investigators in accordance with the FDA Good Clinical Practices (GCP) and, if required by the applicable Proposal, Non-Clinical Studies must be conducted in accordance with the FDA Good Laboratory Practices (GLP).

• Approved Investigators will be responsible for conducting such approved Clinical or Non-Clinical Studies included in the Research Plan.

• NCI will facilitate the solicitation and receipt and approval of Proposals for Non-Clinical Studies contemplating the use of Collaborator’s Formulary Agents.

• If mutually agreed upon by the Parties, IC may conduct Non-Clinical Studies with the Test Article.

• In pursuing the development of Investigational Agent pursuant to this CRADA, NCI utilizes NCI Investigators that are not NCI employees for part or all of the completion of this Research Plan, which may cover Non-Clinical Studies and clinical studies, through Funding Agreements and MTAs. Participation in DCTD-sponsored clinical trials by these investigators shall be determined after competitive solicitation and review of Protocol Letters of Intent (XXXx) or concepts and Protocols by CTEP, NCI.

More Definitions of Non-Clinical Studies

Non-Clinical Studies means exploratory in vitro, in vivo, and ex vivo studies using defined biological models including cell lines, xenograft models, circulating tumor cells, normal tissue, blood and any of its components and shall include ancillary correlative studies, proof-of-mechanism and proof-of-principle assays, development of imaging techniques, and evaluation of target linkage. Non-Clinical Studies may include studies using human materials derived from clinical trials (such as primary, metastatic, or circulating tumor cells, normal tissue, blood and any of its components). This defined term shall be limited to studies under this CRADA. Non-Clinical Studies can be performed by Clinical Investigators or Non-Clinical Investigators. Non-Clinical Studies under this CRADA shall not include DCTD Clinical Support Assays.

Non-Clinical Studies means exploratory in vitro, in vivo, and ex vivo studies using defined biological models including cell lines, xenograft models, circulating tumor cells, normal tissue, blood and any of its components and shall include ancillary correlative studies, proof-of-mechanism and proof-of-principle assays, development of imaging NCI DCTD CRADA model adopted October 14, 2011 Case Ref. No. 00-0-00000 Page 6 of 33 Confidential techniques, and evaluation of target linkage. Non-Clinical Studies may include studies using human materials derived from clinical trials (such as primary, metastatic, or circulating tumor cells, normal tissue, blood, and any of its components). This defined term shall be limited to studies under this CRADA. Non-Clinical Studies can be performed by Clinical Investigators or Non-Clinical Investigators. Non-Clinical Studies under this CRADA shall not include DCTD Clinical Support Assays.

Non-Clinical Studies means all non-human studies of Licensed Compounds and Licensed Products.

Non-Clinical Studies means non-human studies of Licensed Products, including chemistry, manufacturing and control-related studies.

Non-Clinical Studies means exploratory in vitro, in vivo, and ex vivo studies conducted under this Agreement such as ancillary correlative studies, proof-of-mechanism and proof-of- principle assays, development of imaging techniques or evaluation of target linkage. These studies may focus on animal or human materials using defined biological models including cell lines, xenograft models, circulating tumor cells, normal tissue, blood and any of its components.

Non-Clinical Studies means all non-human tests and studies of New Collaboration Compounds (including Lead Compounds, Development Candidates and Product Candidates) and Products. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.

Non-Clinical Studies means all preclinical and non-clinical studies, including in vitro, in vivo and ex vivo studies of Compounds or Products.