* 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.
The C [sub]max of formulation D passed the bioequivalence
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".
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.