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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All of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence interval of 80-125%.
We have demonstrated the process's feasibility and confirmed the bioequivalency of Tc-99m produced in a high-performance cyclotron compared to that produced in a nuclear reactor.
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.
In the near-term, ChemImage will work with generic drug manufacturers to lower their risk when going into clinical trials by providing them with additional bioequivalency data.
meet the same high safety and efficacy standards of our FDA including bioequivalency standards?
for bioequivalency tests, needed to procure FDA approval, constituted
During this period, 35 new laboratories for bioequivalency assays were built.
The latest formulation of the drugs did not achieve the same bioequivalency as individual doses of the medications, Gilead officials said.
Bioequivalency in humans has NEVER been rigorously demonstrated between two different "natural bioactive" heteromolecular compositions claiming to be chemically equivalent.