For approval of generic drug products, bioequivalence testing is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products based on the Fundamental Bioequivalence Assumption that when two drug products (e.g., a brand-name drug and its generic copy) are equivalent in bioavailability, they will reach the same therapeutic effect. Although bioavailability for...

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...

a bioequivalence study of two verapamil formulations (generic verapamil tablets and isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. moreover, the feasibili...

Purpose: To investigate the pharmacokinetics of of a developed metoprolol and a reference standard (Mepressor). Methods: Metoprolol tartrate-loaded Eudragit FS microparticles were formulated and compressed into tablets. The tablets were tested for their physicochemical properties according to United States Pharmacopoeia (USP) criteria. In vivo studies of the formulations were carried out in 28 ...

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...

We give a new simpler proof along with a generalization for the inequality of Yao and Iyer [10] arising in bioequivalence studies and by using a nonparametric approach we also discuss an extension of the individual bioequivalence setting to the case where the data are not necessarily normally distributed.

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin(®) tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibi...

Increased use of whole effluent toxicity (WET) tests in the regulatory arena has brought increased concern over the statistical analysis of WET test data and the determination of toxicity. One concern is the issue of statistical power. A number of WET tests may pass the current hypothesis test approach because they lack statistical power to detect relevant toxic effects because of large within-...