BACKGROUND Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokin...

INTRODUCTION The generic drugs program provided a better population's access to medicines. To ensure interchangeability between a brand-name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequiva...

Background: Deferasirox is an orally bioavailable synthetic, tridentate iron chelator that binds iron at a 2:1 ratio. The generic brand for this drug is still not available in Indonesia. We aimed to compare the efficacy between the generic drug and its innovator (Exjade®) by a study of bioequivalence in Indonesia among healthy volunteers. Methods: An open-label, single-dose, two-sequence, rand...

Bioequivalence studies are the commonly accepted methods displaying therapeutic equivalence between two products .This study was conducted to evaluate the bioequivalence between different formulations of metformin 500 mg and 1000 mg tablets which were marketed in Iran, and innovator brand. Considering that only in vitro bioequivalence studies can predict the in vivo bioequivalence, and to save ...

When an innovative (brand-name) drug is going off patent protection, the innovative drug companies and/or generic drug companies may file an abbreviated new drug application (ANDA) for generic approval through the conduct of a bioequivalence study. Bioequivalence testing for generic approval is based on the Fundamental Bioequivalence Assumption that when two drug products have similar drug abso...

The aim of the evaluation was to establish bioequivalence between two oral 3.0 g sachet forms of L-ornithine-L-aspartate (LOLA). It was designed as randomised, two-way crossover study with a 1-week washout interval. Blood samples were collected throughout a 12 h period after administration of reference and test product to 12 fasting healthy male volunteers. Plasma were analyzed by sensitive, re...

A simple and rapid HPLC-UV method has been developed for determination of levofloxacin in human plasma. Chromatographic separation was performed on a Kromasil C18 column with the mobile phase consisting of acetonitrile, water, phosphoric acid and triethylamine (14:86:0.6:0.3, v/v/v/v) and flow rate was 1.0 mL/min. The method used ultraviolet detection set at a wavelength of 294 nm. The standard...

Nirmatrelvir is an antiviral drug that, in combination with ritonavir, effective agent for the etiotropic therapy of patients mild to moderate COVID-19. The aim study was evaluate bioequivalence generic nirmatrelvir Аrpaxel ritonavir and original Paxlovid, which a nirmatrelvir/ritonavir, single dose administration healthy volunteers. Materials methods. This research open-label, randomized, two-...

Introduction: The generic drugs program provided a better population’s access to medicines. To ensure interchangeability between a brand-name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequiv...