Bioequivalence definition

Bioequivalence means that two proprietary preparations of a drug, when administered in the same dose and by the same route, will have the same bioavailability, duration of action and efficacy.

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Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study

Bioequivalence means, a biological product that (i) is highly similar to the Product notwithstanding minor differences in clinically inactive components; and (ii) has no clinically meaningful differences between the biological product and the Product in terms of the safety, purity, and potency.

Examples of Bioequivalence in a sentence

• It is the belief of the Parties that only one (1) pivotal Bioequivalence Study will be required to obtain the approval of both Product strengths because they will be dose-proportional.

• 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.

• In addition, Tishtec will immediately provide ▇▇▇▇▇▇ and Elite copies of any correspondence form or to the FDA or other regulatory authorities related to the clinical trials, including but not limited to any FD-483s or warning letters, as well as any other correspondence with a governmental agency that is reasonably likely to affect the suitability of Tishtec or such third party to continue conducting the Bioequivalence Study.

• 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.

More Definitions of Bioequivalence

Bioequivalence means the absence of a significant difference in the bioavailability between two pharmaceutically equivalent products under similar conditions in an appropriately designed study;

Bioequivalence means for purposes of QD Product or BID Product, as applicable, the least square mean ratios (test/reference) for the point estimates of Cmax and AUC (Cmax, AUCt, AUCinf and AUCtau, as applicable) are between 0.8 and 1.25.

Bioequivalence means the absence of a significant difference in the bioavailability between two

Bioequivalence means that two pharmaceutical products which are pharmaceutically equivalent or pharmaceutical alternatives, and their bioavailabilities, in terms of rate (Cmax and Tmax) and extent of absorption (area under the curve), after administration of the same molar dose under the same conditions, are similar to such a degree that their effects can be expected to be essentially the same

Bioequivalence means two pharmaceutically equivalent or pharmaceutical alternative products having their bio availabilities after

Bioequivalence or "Bioequivalent" shall mean ****.

Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study”, FDA Code of Federal Regulation § 320.1. (e), available at: ▇▇▇▇://▇▇▇.▇▇▇▇▇▇.▇▇▇/cfr/title21/21- 5.0.1.1.7.html#21:5.0.1.1.7.1.1.1), accessed on 2 June 2012.