bioequivalence


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bi·o·e·quiv·a·lent

 (bī′ō-ĭ-kwĭv′ə-lənt)
adj.
Acting on the body with the same strength and similar bioavailability as the same dosage of a sample of a given substance. Used of differing formulations of a drug or chemical compound.

bi′o·e·quiv′a·lence n.
Translations

bioequivalence

n bioequivalencia
References in periodicals archive ?
Biopharmaceutical company Biohaven Pharmaceutical Holding Company Ltd (NYSE:BHVN) and its wholly owned subsidiary Biohaven Pharmaceuticals Inc, on Friday jointly announced the treatment of the first subject to demonstrate the pharmacokinetic equivalence of sublingual BHV-0223 compared to Rilutek (riluzole) as a potential treatment for Amyotrophic Lateral Sclerosis (ALS) under a bioequivalence study.
A senior official of the ICCBS, University of Karachi, said on Monday that under this agreement both organizations will collaborate in the areas of bioequivalence studies and clinical trial projects to strengthen the pharmaceutical industry.
In this article, we examined the Brazil's current regulation for prescription drug substitutability in light of the concepts of drug bioavailability, relative bioavailability and bioequivalence.
The authors have organized the thirteen chapters that make up the main body of their text in five parts devoted to bioequivalence and biopharmaceutical development, special types of bioequivalence, clinical pharmacology, vaccines, and a wide variety of other related subjects.
Alternatively, Chow and Shao [1] proposed considering a confidence region approach (which we will refer to as a twoparameter approach) for assessing average bioequivalence.
The aim of the present study was therefore to determine the bioequivalence of RFP in FDC formulations compared with RFP in free combinations in healthy Chinese male volunteers.
The Vice Chancellor viewed that bioequivalence study of the local drugs would build confidence of the consumer on its efficacy and resultantly enhance exports.
But the Food and Drug Administration "has determined that this approach is no longer appropriate" to establish bioequivalence and "is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.
The bioequivalence problem was confirmed in an FDA-sponsored study conducted in 2010, comparing the bioequivalence of the Impax/Teva product to Wellbutrin XL 300 mg in 24 healthy adults, which determined that the generic tablets "fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg," according to the statement.
As it is known, drugs with proven bioequivalence are reliable and inexpensive alternative drugs-brands and provide treatment required for all (Meshkovskii, 2003; Belousov, 2003; Panyushin, 2003).
The Citizen Petition provides data that highlights several key points for the FDA's consideration, including comparative pharmacokinetic (PK) studies with a state-of-the-art method that it asserts should be required to demonstrate bioequivalence of a purported generic Copaxone.