Pre-Phase I definition

Pre-Phase I means the initial portion of a development program prior to initiation of a Phase I Study, which starts with the selection of a compound and includes initiation of GMP scale-up activities and GLP toxicological studies. For illustrative purposes, Pre-Phase I development activities typically include toxicological (full-scale GLP toxicology for obtaining approval from a Regulatory Authority to administer Product to humans in clinical trials), pharmacological and any other studies required for filing an IND, as well as Product formulation and manufacturing development necessary to obtain the permission of Regulatory Authorities to begin a Phase I Study.
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Pre-Phase I means that portion of the Development Program that starts with the selection of a Collaboration Compound for Development by OMP into a Collaboration Product or the beginning of toxicological studies related to such Collaboration Compound. Pre-Phase I includes, but is not limited to, toxicological, pharmacological and any other studies, the results of which are required for filing IND, as well as Collaboration Product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue subsequent human clinical testing. Toxicology as used in this definition means full-scale toxicology using “Good Laboratory Practices” for obtaining approval from a regulatory authority to administer the Collaboration Product to humans. This toxicology is distinguished from initial dose range finding toxicology, which usually includes a single and repeated dose ranging study in two species with less than half of the animals required by the FDA, an ▇▇▇▇ test and a related chromosome test.
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Pre-Phase I means that portion of the development program that starts with the selection of a compound for development into the Licensed Product or the beginning of toxicological studies relating to such compound. Pre-Phase I includes, without limitation, toxicological, pharmacological and any other studies, the results of which are required for filing with an IND, as well as Licensed Product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue subsequent human clinical testing. Toxicology, as used in this definition, means full scale toxicology using "Good Laboratory Practices" for obtaining approval from a regulatory authority to administer the Licensed Product to humans. This toxicology is distinguished from initial dose range finding toxicology, which usually includes a single and repeated dose ranging study in two species with less than half of the animals required by the FDA, an ▇▇▇▇ test and a related chromosome test.
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Examples of Pre-Phase I in a sentence

  • In the event that the Company makes a Safety Decision in respect of a Pre-Phase I Product any license rights granted to the Foundation or any Foundation-Supported Entities or sub-licensees of either of them with respect to such Pre-Phase I Product shall be limited to non-human uses of such product.

  • The Foundation therefore agrees that prior to the completion of a Phase I Clinical Study in respect of a Phase I Product (a “Pre-Phase I Product”) the Company may decide, at its reasonable discretion, acting in good faith and following good faith consultations with the Foundation, that upon review of the available pre-clinical and clinical data that to administer said Pre-Phase I Product to a human subject would place such subject at unacceptable risk of harm (a “Safety Decision”).

  • The cost for Pre-Phase I as $93,720 using the hours and hourly rates detailed within this response.

  • PRI shall be solely responsible for and have the sole right to select a Collaboration Product to enter Pre-Phase I.

  • The Buy American provision requirements as stated in section 104(d) of the ▇▇▇▇▇▇▇ ▇.

  • Once a Direct Thrombin Inhibitor is selected to enter Pre-Phase I, Centocor shall have the sole right to Develop the Direct Thrombin Inhibitor (except as provided in Section 4.7), including, but not limited to, preparing, filing and exclusively owning, all Drug Approval Applications and obtaining and exclusively owning all Regulatory Approvals on a worldwide basis.

  • The following table details our team’s involvement (hours) in Pre-Phase I which underlies the $93,720 pricing.

  • Once a Collaboration Product is selected to enter Pre-Phase I, PRI shall be solely responsible for and shall have the sole right to develop the Collaboration Product through Pre-Phases I and Phases I, II and III including making all Drug Approval Applications and obtaining all Regulatory Approvals on a worldwide basis.

  • Additionally, Centocor may, without the consent of 3DP, contract with reputable contract research organizations to conduct or assist in the conduct of (i) Pre-Phase I activities and (ii) human clinical **Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission.

  • For illustrative purposes, Pre-Phase I development activities typically include toxicological (full-scale GLP toxicology for obtaining approval from a Regulatory Authority to administer Product to humans in clinical trials), pharmacological and any other studies required for filing an IND, as well as Product formulation and manufacturing development necessary to obtain the permission of Regulatory Authorities to begin a Phase I Study.


More Definitions of Pre-Phase I

Pre-Phase I means that portion of the development program which starts with the selection of a compound for development into a Product or the beginning of toxicological studies relating to such Product. Pre-Phase I includes, but is not limited to, toxicological, pharmacological and any other studies, the results of which are required for filing with an IND, as well as product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue subsequent human clinical testing. Toxicology as used in this definition means full-scale toxicology using CGMP material for obtaining approval from a regulatory authority to administer the Product to humans. This toxicology is distinguished from initial dose range finding toxicology, which usually includes a single and repeated dose ranging study in two species with less than half of the animals required by the FDA, an A▇▇▇ test or a related chromosome test.
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Pre-Phase I means the initial portion of a development program prior to initiation of a Phase I Study, which starts with the selection of a NME and includes initiation of GMP scale-up activities and GLP toxicological studies. For illustrative purposes, Pre-Phase I development activities typically include toxicological (full-scale GLP toxicology for obtaining approval from a Regulatory Authority to administer Product to humans in clinical trials), pharmacological and any other studies required for filing an IND, as well as Product formulation and manufacturing development necessary to obtain the permission of Regulatory Authorities to begin a Phase I Study.
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Pre-Phase I means the initial portion of a development program prior to initiation of a Phase I Study, which starts with the selection of a compound and includes initiation of GMP scale-up activities and
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Pre-Phase I means that portion of the development program which starts with the selection of a Collaboration Product for development and the beginning of at least toxicological studies relating to such compound. Pre- Phase I includes, but is not limited to, toxicological and pharmacological studies and manufacturing development, including scale up for clinical supplies, necessary to obtain the permission of regulatory authorities to begin and continue subsequent human clinical testing.
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Pre-Phase I means that portion of the development program which starts with the selection of a compound for development into a Product or the beginning of toxicological studies relating to such compound. Pre-Phase I includes, but is not limited to, toxicological, pharmacological and any other studies, the results of which are required for filing with an IND, as well as product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue subsequent human clinical testing. Toxicology as used in this definition means full-scale toxicology using CGMP material for **Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission. obtaining approval from a regulatory authority to administer the Product to humans. This toxicology is distinguished from initial dose range finding toxicology, which usually includes a single and repeated dose ranging study in two species with less than half of the animals required by the FDA, an ▇▇▇▇ test or a related chromosome test.
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Pre-Phase I means that portion of the development program which starts with the selection of a compound for development by Janssen into a Product or the beginning of toxicological studies relating to such compound. Pre-Phase I includes, but is not limited to, toxicological, pharmacological and any other studies, the results of which are required for filing with an IND, as well as Product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue subsequent human clinical testing. Toxicology as used in this definition means full scale toxicology using "Good Laboratory Practices" for obtaining approval from a regulatory authority to administer the Product to humans. This toxicology is
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Related to Pre-Phase I

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • Phase III means a human clinical trial of a Licensed Product, which trial is designed to: (a) establish that a Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; (c) support regulatory approval of such Licensed Product; and (d) be generally consistent with 21 CFR § 312.21(c). Said trial may be conducted in any country.

  • Phase I means the first part of the tuition incentive assistance program defined as the academic period of 80 semester or 120 term credits, or less, leading to an associate degree or certificate.

  • Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and ▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇ the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • Development Phase means the period before a vehicle type is type approved.