The bioequivalence problem is of practical importance because the approval of most generic drugs in the United States and the European Community (EC) requires the establishment of bioequivalence between the brand-name drug and the proposed generic version. The problem is theoretically interesting because it has been recognized as one for which the desired inference, instead of the usual signifi...

The aim of bioequivalence studies is the evaluation of bioequivalence of pharmaceutical products. The products are usually two and basic pharmacokinetic parameters such as AUC, C max and t max are used. These studies aim at investigating the “closeness” of the distributions of the pharmacokinetic parameters (responses) for the two products, which is made mainly by comparing the average values o...

It is a one-sided hypothesis testing process for assessing bioequivalence. Bootstrap and modified large-sample(MLS) methods are considered to study individual bioequivalence(IBE), type I error and power of hypothesis tests are simulated and compared with FDA(2001). The results show that modified large-sample method is equivalent to the method of FDA(2001) . Keywords—individual bioequivalence; b...

The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, randomized-sequence, open-label, four-way crossover study with a one-day washout period between dose...

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...

After more than 10 years of implementation in vivo Bioequivalence study, there are 835 drugs licensed to manufacture Vietnam, accounting for 77.89% circulate on the Vietnamese pharmaceutical market period 2012-2022, a worthwhile result. An achievement development In study recent is that state management agency (Ministry Health) has increased required active ingredients submit bioequivalence rep...

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 ...

OBJECTIVE To review current evidence concerning pharmacology of biosimilar candidates to be used in rheumatology. METHODS A PubMed search up to August 2013 was performed using relevant search terms to include all studies assessing pharmacological properties of biosimilar candidates to be used in rheumatology. Data on study characteristics, type of intervention, pharmacokinetics (PK), pharmaco...

Current pharmacokinetic (PK) bioequivalence guidelines do not account for batch-to-batch variability in study design or analysis. Here we evaluate the magnitude of batch-to-batch PK variability for Advair Diskus 100/50. Single doses of fluticasone propionate and salmeterol combinations were administered by oral inhalation to healthy subjects in a randomized clinical crossover study comparing th...