Bioequivalence Studies definition

Bioequivalence Studies means a study undertaken to satisfy the FDA’s requirements for bioequivalence in connection with establishing that a drug product subject to an ANDA is a Therapeutic Equivalent of the Brand Product referenced in such ANDA.
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Bioequivalence Studies means studies to assess the expected in vivo equivalence
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Examples of Bioequivalence Studies in a sentence

  • Without limiting the foregoing, Tishtec shall be responsible for, and shall exert commercially reasonable best efforts in providing to Elite the initial Product formulation composition and process, and conducting, through an acceptable third party, pilot and pivotal Bioequivalence Studies for the Product to evidence bioequivalence to the Reference Listed Drug in accordance with study plan protocols agreed upon by the Parties to this Agreement, and compiling an approvable ANDA for submission to the FDA.

  • IntelGenx shall cooperate fully with Par in connection therewith, and shall promptly provide Par, as requested and at no additional charge, such technical and other assistance, including all available information and data in its control, reasonably necessary or useful for Par to conduct the Pivotal Bioequivalence Studies for such Product.

  • Upon receipt of such notice, Par shall, subject to the negotiation and execution of a written agreement by Par and lntelGenx in respect thereof, grant IntelGenx an exclusive, royalty-bearing license to use and have access to any information or Intellectual Property disclosed within the Product ANDA for such Product, including the results of the Pivotal Bioequivalence Studies for such Product, for the sole purpose of commercializing such Product outside the Territory.

  • All development work, other than the [***] Pivotal Bioequivalence Studies for a Product, shall be conducted by IntelGenx at IntelGenx's facilities; provided, however, that all work relating to process scale-up and Submission Batches for a Product shall be conducted, at Par's direction based on IntelGenx's formulation and manufacturing guidelines, at the Manufacturer's facilities.

  • IntelGenx shall cooperate fully with Par in connection therewith, and shall promptly provide Par, as requested and at no additional charge, such technical and other assistance, including all available information and data in its control, reasonably necessary or useful for Par to conduct the Pivotal Bioequivalence Studies.

  • Upon receipt of such notice, Par shall, subject to the negotiation and execution of a written agreement by Par and IntelGenx in respect thereof, grant IntelGenx an exclusive, royalty-bearing license to use and have access to any information or Intellectual Property disclosed within the Product ANDA, including the results of the Pivotal Bioequivalence Studies, for the sole purpose of commercializing the Product outside the Territory.

  • For the avoidance of doubt, it is expressly understood and agreed upon by the Parties, that IntelGenx shall have the sole and exclusive right, except to the extent required for Edgemont to comply with its legal obligations as the holder of the NDA, to use any information or intellectual property disclosed within the Product NDA, including the results of the Pivotal Bioequivalence Studies.

  • Harris and Elite shall be resp▇▇▇▇▇▇e for funding the pilot and the pivotal Bioequivalence Studies in their proportionate allocated share of [*] percent ([*]%) Harris and [*] percent ([*]%) Elite as set fo▇▇▇ ▇▇ Exhibit "A".

  • Without limiting the foregoing, [ * ] shall be responsible for, and shall exert commercially reasonable best efforts in providing to Elite the initial Product formulation composition and process, and conducting, through an acceptable third party, pilot and pivotal Bioequivalence Studies for the Product to evidence bioequivalence to the Reference Listed Drug in accordance with study plan protocols agreed upon by the Parties to this Agreement, and compiling an approvable ANDA for submission to the FDA.

  • Harris shall have the final decision as to the clinical research organization used for the pilot and the pivotal Bioequivalence Studies.