Pre-Clinical Studies definition

Pre-Clinical Studies means in vitro and in vivo studies of a Product, not in humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of such Product and whether such Product has a desired effect.
Pre-Clinical Studies means in vitro and in vivo studies of a Collaboration Compound, not in humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of a Collaboration Compound and whether the Collaboration Compound has a desired effect. ***Confidential Treatment Requested
Pre-Clinical Studies shall have the meaning given in Section 4.02.

Examples of Pre-Clinical Studies in a sentence

  • Intraoperative Laser Speckle Contrast Imaging For Real-Time Visualization of Cerebral Blood Flow in Cerebrovascular Surgery: Results From Pre-Clinical Studies.

  • Nothing in this Article shall restrict any Party from using for any purpose any Confidential Information independently developed by it without access to or use of the other Party’s Confidential Information during the term of this Agreement, or from using Confidential Information that is specifically derived from Pre-Clinical Studies or Clinical Studies to perform marketing, sales or professional services support functions as is customary in the pharmaceutical industry.

  • The Basic Science Behind Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: A Systematic Scoping Review of Pre-Clinical Studies.

  • Regulus shall [...***...] use its Diligent Efforts to manufacture pre-clinical supplies and clinical supplies of Collaboration Compounds, including all bulk drug substance, for all Pre-Clinical Studies and Clinical Studies, including process development and scale-up, conducted by Regulus under such Program during the Program Term for such Program.

  • IV.A Pre-Clinical Studies Pharmacology PharmacodynamicsThe applicant has provided a literature review covering relevant pharmacodynamics information for each of the active substances and potential interactions between the active substances have been addressed separately in four GLP studies.

  • The road construction solely for the purpose of tea-tree harvesting is prohibited.

  • In relation to Pre-Clinical Studies, oral reports or interim written status reports of the progress of the Studies will be provided by the Principal Investigator to Adaptimmune on a regular basis and at least once every *** (***) months during the *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

  • LA.; Sill, Martin; and Schaarschmidt, Frank (2010): Evaluation of Incidence Rates in Pre-Clinical Studies Using a Williams-Type Procedure, The International Journal of Biostatistics: Vol.

  • A Novel Buccal Implantation Approach to Orthotopic Mouse Models of Head and Neck Squamous Cell Carcinoma for In Vivo Pre-Clinical Studies.

  • The Court should remand, as FERC’s departure from precedent is neither “reasonable [nor] reasonably explained.” ANR Storage Co. v.


More Definitions of Pre-Clinical Studies

Pre-Clinical Studies means studies of a Licensed Product in animals for the purpose of assessing preliminary efficacy, toxicity, pharmacokinetic and safety information.
Pre-Clinical Studies means biomedical studies not performed on human study participants;
Pre-Clinical Studies means any studies in animal subjects to evaluate safety or efficacy.
Pre-Clinical Studies. FDA" and "NDA" as used in Section 4 hereof and "Affiliate" and "Schering Group" as used in Section 7 hereof shall have the meanings set forth in the Development Agreement.
Pre-Clinical Studies means animal studies, in vitro studies, cadaver studies and other similar studies associated with the research, development and manufacture of Surgical Products. Notwithstanding the foregoing, PLC shall not be responsible for human clinical studies.

Related to Pre-Clinical Studies

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.