Introduction. As a part of the registration drug product bioequivalence study fixed-dose combination "Ezetimibe + rosuvastatin" (JSC "Sanofi-aventis group", Russia) compared with coadministered Ezetrol® (ezetimibe) and Crestor® (rosuvastatin) was conducted 76 healthy volunteers. Enzymatic hydrolysis used to evaluate pharmacokinetics total ezetimibe. This reason for inclusion additional monitore...

BACKGROUND In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (ie, is bioequivalent to) the innovator drug product. Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies. OBJ...

Timely and proper injection of epinephrine is critical to prevent serious consequences relating to anaphylaxis. In a recent bioavailability study comparing epinephrine delivery from the Auvi-Q™ and EpiPen(®) epinephrine autoinjectors, the Auvi-Q failed to meet the bioequivalence threshold when using partial area under the curve (AUC) analyses based on zero to Tmax recommended for highly variabl...

Genetically modified (GM) corn hybrids have been recently compared against their isogenic reference counterparts in order to establish proof of safety as feedstuffs for dairy cattle. Most such studies have been based on the classical hypothesis test, whereby the null hypothesis is that of equivalence. Because the null hypothesis cannot be accepted, bioequivalence-testing procedures in which the...

Oral administration of endogenous substances in most cases results in negligible net increases in baseline plasma concentrations, associated with high variability. This poses the problem of their bioequivalence. Using the data obtained from a bioequivalence investigation of potassium aspartate (test vs reference formulation), the authors demonstrate the inconsistency of bioequivalence based on ...

Bioequivalence testing aims to ensure that the therapeutic performance of drug is consistent and reproducible when it administrated. Modeling simulation in silico methods are currently performed conduct virtual bioequivalence studies. Various computer software used generate model input data. This review summarizes for predicting vivo which supports analysis testing. GastroPlus™ SimCyp® widely p...

Testing the equivalence of treatments in a two-period crossover design setting occurs often in the pharmaceutical industry. These studies usually compare the rate and extent of absorption of two different drugs or two formulations of the same drug, where one is the accepted standard therapy. The commonly accepted rule for concluding bioequivalence requires the 90% confidence interval for the me...

PURPOSE The assessment of the degree of skin blanching following the application of a formulation containing a topical corticosteroid has been established as a surrogate method for the determination of bioequivalence. In this study, both visual and chromametric assessments have been carried out on two topical creams containing clobetasol propionate (0.05%) and the results from both methods are ...