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.
Confidence Interval Approach for Assessing Average Bioequivalence
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.
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
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