Prestudy definition

Prestudy means a pharmacokinetic biostudy which is intended to indicate likelihood of demonstrating bioequivalence of the Product with the Reference Product, typically carried out in a smaller number of volunteers than those required by FDA for pivotal biostudies.
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Examples of Prestudy in a sentence

  • Pre-study lesion biopsy slides from patients in the screening phase will be sent to the central Dermatopathology laboratory for review and histological confirmation as part of the inclusion requirements.

  • Pre-study visits will be conducted consistent with Medpace SOPs. Medpace will provide a pre-study visit report to VIVUS within 10 business days of each visit.

  • Bionutrics’ obligation to conduct such studies with respect to any Product shall be contingent upon the Product’s successful completion of a Prestudy as well as stability testing and successful manufacture and release of finished product for use in the clinical studies.

  • Pre-study briefings will be held to apprise participants of the objectives, sample locations, and chain-of-custody procedures to be followed.

  • In the case of Generic Products, Bionutrics shall start the Pivotal Study within nine (9) months of the completion the respective Prestudy.

  • Subject to the provisions of Section 9.6, all data and results obtained or generated by or on behalf of either Nostrum or Bionutrics in the performance of any Prestudy, Pivotal Study or other development activities related to the Products to be performed pursuant to this Agreement shall be the sole property of Bionutrics and shall be treated as Bionutrics’ Confidential Information pursuant to Article 5 of this Agreement.

  • Development/Project Initiation/Investigator Contracts [ ] Pre-study Site Evaluation Visits [ ] Study Coordinator Meeting Planning/Attendance/Participation [ ] [ ] National Stroke Assn.

  • Remote Monitoring of Site Data $[****] $[****] No Change No Change Site Visits - Pre-study Visits $[****] $[****] No change No change Site Visits - Initiation Visits $[****] $[****] No change Current costing remains at [****] SIVs. Only costs for visits actually performed will be paid.

  • Pre-study site visits will be conducted at the same time as initiation visits if ▇▇▇▇▇▇▇▇▇▇ or PPD has used the investigational site satisfactorily on a similar study within the preceding twelve (12) months.

  • Pre-study procedures and tumor assessment must be performed within 14 days before first dose of tazemetostat.