Efficacy Study definition

Efficacy Study means a [***].
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Efficacy Study means that portion of the clinical development program in the U.S. or Europe that provides for the initial human testing of a Product at several dosages on a limited number of patients conducted in accordance with the appropriate governmental and institutional regulatory authorities, the intent of which is to demonstrate the presence or absence of pharmacological activity. The initial U.S. Efficacy Study will be similar in scope to the "Italics Protocol" to be carried out at the Thorax Center in Rotterdam under the direction of ▇▇. ▇▇▇▇▇▇▇ Surruys, except that such study shall evaluate [REDACT] so that the patient sample size will be [REDACT]. Except as set forth in the immediate preceding sentence, the protocol for the initial U.S. Efficacy Study shall be substantially similar to the latest draft of the "Italics Protocol" provided to Tanabe prior to the Effective Date, and Lynx shall make no substantial modifications thereto that reduce the scope or substantially change the endpoints without the prior express written consent of Tanabe, which shall not be unreasonably withheld nor require more than 30 days review.
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Examples of Efficacy Study in a sentence

  • Drug Efficacy Study Implementation — Drug products that have been classified as less-than-effective by the FDA.

  • The MCO must not provide coverage under any circumstances for drug products that have been classified as less-than-effective by the Food and Drug Administration (FDA) Drug Efficacy Study Implementation (DESI).

  • Drug Efficacy Study Implementation (DESI) — Drug products that have been classified as less-than-effective by the Food and Drug Administration (FDA).

  • Drug Efficacy Study Implementation (DESI) — Drug products that have been classified as less-than-effective by the FDA.

  • The Contractor shall not provide coverage for Drug Efficacy Study Implementation (DESI) drugs under any circumstances.

  • Phase 3 Global Efficacy Study, Adults ≥ 18 and < 75 years Study: Phase 3 – Global Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301.

  • For these purposes, (a) “DESI” means Drug Efficacy Study and Implementation whereby drugs may be found to be LTE or IRS, (b) “LTE” means less than effective as determined by the Food and Drug Administration and (c) “IRS” means identical, related or similar to DESI or LTE.

  • No Products subject to regulation under the FDA’s Drug Efficacy Study Implementation program are manufactured at any Company Manufacturing Facility.

  • Purchaser acknowledge that (i) not all of the Products are marketed pursuant an approved NDA or ANDA and that some of the Products may be considered to have DESI (Drug Efficacy Study Implementation) regulatory status, and (ii) Seller is not making any representations regarding the regulatory status or future marketability of any Products considered to have DESI regulatory status.

  • The currently marketed phenobarbital formulations are notified under the DESI (Drug Efficacy Study Implementation) program list by the U.S. Department of Health and Human Services.