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...

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...

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 ...

Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products. In this study, we sought to systematically assess the current trends of ongoing and recently completed bioequivalence and bioavailability trials that have been registered within a nation...

Bioequivalence trials are usually conducted to compare two or more formulations of a drug. Simultaneous assessment of bioequivalence on multiple endpoints is called multivariate bioequivalence. Despite the fact that some tests for multivariate bioequivalence are suggested, current practice usually involves univariate bioequivalence assessments ignoring the correlations between the endpoints suc...

The Ministry of Health is constantly emphasizing the quality, efficacy and safety of pharmaceutical products to safeguard the Malaysians public1. The Drug Control Authority at its 92nd meeting has decided to review the registration of generic products to include bioequivelent studies requirement for certain categories of oral immediate release products2 Bioavailability testing of drug products ...