The bioequivalence problem is of practical importance because the approval of most generic drugs in the United States and the European Community (EC) requires the establishment of bioequivalence between the name brand drug and the proposed generic version. The problem is theoretically interesting because it has been recognized as one for which the desired inference, instead of the usual signiic...

Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements this procedure, as described variety documents, differ certain features aspects. These differences need to be analysed. The aim study was compare international Russian regulatory approaches Biopharmaceutics Classification System-based biowaivers, provid...

INTRODUCTION Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states. METHODS A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an...

BACKGROUND Tramadol hydrochloride is available as 50 mg immediate-release (IR) and 100 mg, 200 mg, and 300 mg sustained-release (SR) tablets. The recommended dose of tramadol is 50-100 mg IR tablets every 4-6 hours. The tramadol SR 200 mg tablet is a better therapeutic option, with a reduced frequency of dosing, and improved patient compliance and quality of life. The present study evaluated th...

Objective: To determine the bioequivalence of two marketed test formulations (A, B) as compared to a reference formulation (R) of slow release theophylline in healthy volunteers. Material and Methods: The study was conducted as an open label, balanced, randomized, threetreatment, three-period, three-sequence single-dose crossover study to determine the bioequivalence of Phylobid 200 mg SR table...

Bioequivalence assessment is an issue of great interest. Development of statistical methods for assessing bioequivalence is an important area of research for statisticians. Bioequivalence is usually determined based on the normal distribution. We relax this assumption and develop a semi-parametric mixed model for bioequivalence data. The proposed method is quite flexible and practically meaning...

The article provides an extensive analysis of the data obtained in bioequivalence studies, which can be considered for further evaluation development general and individual therapeutic regimens. Concrete two studies compared amiodarone formulations included plasma levels active metabolite desethylamiodarone. mean variability concentrations pharmacokinetic parameters. In addition, a global struc...

The bioequivalence problem is of practical importance because the approval of most generic drugs in the United States and the European Community (EC) requires the establishment of bioequivalence between the brand-name drug and the proposed generic version. The problem is theoretically interesting because it has been recognized as one for which the desired inference, instead of the usual signifi...

In this study, an open, double-blind, randomized, two-period, two-group crossover design was conducted in 14 healthy volunteers to study the bioequivalence of a fixed-dose generic product. After administration of test or reference products to each volunteer, both active ingredients were determined simultaneously in plasma samples using a developed and validated HPLC-UV method, and pharmacokinet...

AIMS This bioequivalence study was conducted to assess the bioequivalence of two formulations, test and reference, of pregabalin 300 mg hard capsules, under fasting conditions. METHODS This was a single-center, randomized, single-dose, open-label, laboratory-blinded, two-way crossover study, with a minimum washout period of 7 days. Plasma samples were collected prior to and up to 36 h after d...