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

/bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability.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.

bioequivalence

the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability.
References in periodicals archive ?
However, the CBSCR will support TSCL in term of conducting bioequivalence research studies for the pharmaceutical company.
It is of note that a bioequivalence assay is typically a two-treatment crossover study design involving a limited number of adult volunteers (24 to 36) who receive single oral doses of a test drug and its reference product (4,6,10).
Currently, more than 20 brands of clarithromycin tablet formulations are obtainable from our national market5, but reported data of their bioequivalence with special reference to currently executed clinical trial followed by in-vivo quantitation by HPLC coupled with UV detection can rarely be found.
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.
Study of bioequivalence was performed using the in vitro test "Dissolution".
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.
ChemImage's laboratory services utilize the Falcon II system to enable generic drug developers to obtain drug particle sizing of nasal spray suspension, something drug makers have been unable to achieve in the past a= s part of bioequivalence testing.
Hyderabad, Mar 18 (ANI/Business Wire India): The GVK Biosciences (GVK BIO) Clinical Pharmacology Unit at Hyderabad was inspected by a three-member delegation from Ministry of Health, Turkey and approved for conducting bioequivalence studies.