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 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...

The purpose of research study develops an automated computer statistical procedure to determine sample size from a pilot bioequivalence study for a future pivotal bioequivalence study. The sample size is critical in a pivotal bioavailability/ bioequivalence study, and was often estimated from a pilot study. A comprehensive review of current literature reveals that the software for sample size d...

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...

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...

AIMS To assess pharmacokinetics (PK) and safety of GP2015, a proposed etanercept biosimilar, in two studies: comparison with etanercept originator (ETN, bioequivalence study) and comparison of GP2015 administered via an autoinjector (AI) or prefilled syringes (PFS, delivery study). METHODS Both studies were randomized, two-sequence, two-period, crossover studies conducted in healthy male subj...

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...