Laboratory Study definition

Laboratory Study means any in vivo or in vitro experiment in which a “test article”, as such term is defined under the Federal Food, Drug, and Cosmetic Act and its implementing regulations promulgated by FDA, is studied prospectively in test systems under laboratory conditions to determine its safety or any experiment involving the prospective study of a “test article” in any animal. The term does not include studies utilizing human subjects or Clinical Trials. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.
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Examples of Laboratory Study in a sentence

  • Moffitt CCRI shall prohibit any Moffitt CCRI employee faculty member who serves as the designated principal investigator on any Laboratory Study sponsored by Company and conducted by Moffitt pursuant to an Underlying Agreement (each such Laboratory Study, an “Exclusive Alliance Lab Study”) from [***].

  • Software License Agreement – End-User Software License Agreement - Source Code Sponsored Clinical Study Agreement Sponsored Laboratory Study Agreement or Testing Agreement Sponsored Research Agreement - No IP Sponsored Research Agreement - Univ.

  • Salt, Ph.D. and Parent, (c) Preclinical Laboratory Study Agreement, dated as of June 29, 2007, by and between Parent, University of Miami Ear Institute and ▇▇▇▇▇▇ Van De Water, Ph.D. and 4 (d) Laboratory Services Agreement, dated as of April 10, 2007, by and among Parent and Microbiology Research Associates, Inc.

  • If such Services or any activity to be performed by LakePharma under the Work Order will be submitted by Client as a Nonclinical Laboratory Study submission (“GLP Study”) to the FDA in support of a research or marketing application, Client shall so notify LakePharma and the applicable Work Order shall so provide.

Related to Laboratory Study

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.