bioequivalency

bioequivalency

The acting of drug A (e.g., a generic) in the body in the same manner and to the same degree as drug B (e.g., a proprietary agent), to which it is being compared.
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The Hatch-Waxman Act recognized the need for a published compendium of generics passing bioequivalency testing.
A strict registration mechanism validates, among multiple quality controlling factors, the manufacturing conditions and drug bioequivalency, enabling the government to control comparisons of generics to originators and to clearly indicate the equivalence.
This edition has been updated to include new findings in drug delivery and dosage form design and revised worldwide regulatory requirements, as well as new topics like the history of generic pharmaceuticals, new guidelines for submissions related to bioequivalency studies, models of noninferiority, the biosimilarity of large molecule drugs, the bioequivalence of complementary and alternative medicines, biosimilar therapeutic proteins and monoclonal antibodies, new FDA guidelines for bioanalytical method validation, outsourcing and monitoring bioequivalence studies, and the future of the field.
After prior consultation with the US FDA, Celltrion conducted additional clinical trials (starting on October 2013 and lasting 6 months) to determine the bioequivalency of the originator products with Remsima.
The company added that the data from its Phase 1 trial of its anti-psoriasis drug candidate Prurisol for the conversion of Prurisol to abacavir is now within passing the Bioequivalency limits.
86) By overruling Bolar, the Hatch-Waxman Act allows a generic manufacturer to use a patented product to conduct bioequivalency studies for the ANDA process.
1) The Hatch-Waxman Act created an abbreviated pathway for generic versions of brand drugs to get Food and Drug Administration (FDA) approval by permitting the use of brand clinical studies to show bioequivalency in the Abbreviated New Drug Application (ANDA) because the active ingredients are identical.
Despite assurances from authorities about its bioequivalency in humans, I believe Premarin is good for postmenopausal mares, while for women, estradiol is more physiological.
33) In Roche, the court held that using the patented product to conduct bioequivalency experiments constituted infringement and could, consistent with general rules of equity, be enjoined.
In one notable case, Betty Dong of the University of California at San Francisco (UCSF) was the principal investigator of a drug company-sponsored contract to evaluate the bioequivalency of the generic and trade versions of a drug.
Battelle-Korea Laboratories is focused on establishing a bio-nanoscience center of excellence to serve the electronics industry, and International Scientific Standard (also in Korea) conducts bioequivalency testing services for the pharmaceutical industry.