bioequivalence


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bioequivalence

 [bi″o-e-kwiv´ah-lens]
the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. adj., adj bioequiv´alent.

bioequivalence

The scientific basis on which drugs with the same active ingredient(s) are compared. Bioequivalence requires that the bioavailability of two drugs must not differ significantly when they are given at the same dosage under similar conditions.
References in periodicals archive ?
* Urging Arab countries to authorize bioequivalence studies and ensuring that they conform to the technical requirements of Good Clinical Practice (GCP) through regular inspection visits.
The FDA defines bioequivalence as "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.
At the request of the Food and Drug Administration, Impax/Teva had started a study comparing the bioequivalence of the 300-mg product with the brand-name product.
The primary analysis assessed the bioequivalence between calcium acetate oral solution and calcium acetate gelcaps on PK parameters up to 6 hours post dose with baseline adjustment using the ratio of Days 3 to -1.
All subjects were briefed on the bioequivalence study details and they all agreed and signed a written informed consent.
Study of bioequivalence was performed using the in vitro test "Dissolution".
The bioequivalence studies required for a new generic are based on pharmacokinetic parameters, most notably, the area under the plasma concentration curve (AUC)--a measure of overall drug exposure--and the maximal plasma concentration ([C.sub.max).
An FDA review of 12 years worth of bioequivalence date found that the average difference in the rate and extent of drug absorption between generics and brand-name drugs was 4.35 and 3.56 percent, respectively, while less than two percent of drugs varied by more than 10 percent.
Although each generic must be tested against the brand-name product for bioequivalence, they do not need to be tested against each other.
Astellas announced it plans to file a complaint for declaratory and injunctive relief in US District Court in Washington, DC challenging the FDA's decision to apply standard bioequivalence testing for the approval of generic immunosuppressive drugs, like tacrolimus.
Baltimore, MD-based Next Breath focuses on conducting in vitro bioequivalence testing for nasal sprays and chemistry, manufacturing and controls (CMC) testing for inhalation and nasal spray products, and is particularly interested in advancing the technology to find a faster and reproducible method for drugparticle sizing relative to bioequivalence studies for nasal spray suspensions.