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...

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-...

The governments of many countries strongly support the production and clinical use of generic medicinal products which are “copies” of patented drugs and can be marked at lower cost. At present time bioequivalence testing is regarded as a useful methodology to perform comparisons among different products containing the same active ingredient. This report presents the results of comparative bioe...

The aim was to assess the bioequivalence of Sandoz methylphenidate osmotic-controlled release (OCR) tablets (Sandoz [Methylphenidate[ MPH OCR) with Concerta®, a methylphenidate formulation indicated for the treatment of attention deficit/hyperactivity disorder (ADHD). Four open-label, randomized, single-dose, two-way crossover bioequivalence studies were conducted in healthy subjects: three fas...

Back in 2009, we concluded that veterinary pharmacology was sorely in need of a bioequivalence initiative. Despite the pharmacological and statistical advances that have occurred since the early days of bioequivalence assessments, unresolved issues remain. While many of these issues are common to both human and veterinary medicine, there are also challenges specific to veterinary drug products....

Testing the equivalence of treatments in a two-period crossover design setting occurs often in the pharmaceutical industry. These studies usually compare the rate and extent of absorption of two different drugs or two formulations of the same drug, where one is the accepted standard therapy. The commonly accepted rule for concluding bioequivalence requires the 90% confidence interval for the me...

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...

Bioequivalence studies on some selected brands of ciprofloxacin hydrochloride tablets in the Nigerian market with ciproflox® as innovator brandOsonwa Uduma E., Agboke Ayodeji A., Amadi Rosemary C., Okorie,Ogbonna, Opurum Christian C

Timely and proper injection of epinephrine is critical to prevent serious consequences relating to anaphylaxis. In a recent bioavailability study comparing epinephrine delivery from the Auvi-Q™ and EpiPen(®) epinephrine autoinjectors, the Auvi-Q failed to meet the bioequivalence threshold when using partial area under the curve (AUC) analyses based on zero to Tmax recommended for highly variabl...

Substitution of branded medicines by cheaper generic medicines has been and is subject for debate in the Netherlands. One of the tasks of the Dutch Medicines Evaluation Board (CBG) is the evaluation of generic medicines. The way the CBG approves generics, as outlined in this paper, is based on assessment of the quality of the medicine and bioequivalence testing according to strict European guid...