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
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
95, respectively, which satisfied the acceptance ranges of WHO and FDA 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  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.
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.