Animal POC definition

Animal POC. Animal POC means gene expression and/or gene function, in an animal model, of the transgene cassette that defines the relevant potential Product.
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Animal POC means the demonstration of efficacy of Collaboration Compounds in at least one animal model performed by or on behalf of Roche during Lead Optimization.
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Animal POC means demonstration of safety and a Pre-agreed level of therapeutic efficacy, including a change in the levels of a Pre-agreed disease relevant biomarker in some cases as a substitute for therapeutic efficacy, in a Pre-agreed animal model.
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Examples of Animal POC in a sentence

  • For borrowers in South Carolina, in addition to the aforementioned costs and expenses, you agree to pay attorney' s fees of 20 % of the unpaid balance of all loans in default or such greater amount as may be reasonable.

  • The “Data Package” shall include the Data (including the releant in-vitro and Animal POC Data, the IND submission documents and/or P1 Clinical Trial Data) for each CAB Antibody to the extent such data is required for Himalaya to develop and commercialize the CAB Antibody or related Product under each Development Plan and Commercialization Plan.

  • Subsequently in the Research Program (i.e., when AAV Capsid Variants have been accepted by uniQure as being ready for Animal POC testing or in parallel with the identification with lead AAV Capsid Variants for Lead [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10).


More Definitions of Animal POC

Animal POC means rodent tumor xenograft studies only.
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Animal POC. Animal POC means demonstration of gene expression and/or gene function of a Transgene cassette for a Target, in an animal model or patient-derived cells; provided that such demonstration shall be in an established, relevant animal model of a disease, if available. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
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Related to Animal POC

  • Genetic resources means genetic material of actual or potential value;

  • Health screening means the use of one or more diagnostic tools to test a person for the presence or precursors of a particular disease.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Animal means any nonhuman animate being endowed with the power of voluntary action.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.