Bioequivalence between two products has to be demonstrated as an essential part of the generic approval process (new formulation vs. innovator product), bridging an innovator’s product from the formulation used in clinical phase III to the marketed formulation, or in case of major variations of an approved product. The most common design of bioequivalence studies is a twosequence two-period two...

This was a Phase I, open-label, randomized, two-period, two-sequence crossover study [ClinicalTrials.gov NCT02317809 (https://www.clinicaltrials.gov/ct2/show/NCT02317809); EudraCT 2014-003506-32] assessing the bioequivalence of the liquid and freeze-dried formulations of fixed-dose, fixed-ratio (2:1) combination recombinant human follicle-stimulating hormone plus recombinant human luteinizing h...

AIMS This bioequivalence study aimed to compare rate and extent of absorption of a generic medicinal product of ibandronic acid 150-mg film-coated tablet versus Bonviva(®). METHODS This was a single-centre, open-label, randomized, three-way, three-sequence, reference-replicated, crossover bioequivalence study, under fasting conditions. A single oral dose of ibandronic acid as one 150-mg film-...

The paper is devoted to various aspects of the organization drug pharmacokinetics research both at preclinical and clinical levels (bioequivalence study, therapeutic monitoring, optimization dosage regimens), as well arrangement work equipment (instrumentation, chemicals, premises, personnels) pharmacokinetic laboratory.

BACKGROUND Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. OBJECTIVE To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. METHODOLOGY/PRINCIPAL FINDINGS PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and Decem...

The present study was designed to assess the bioequivalence of two agomelatine formulations (25-mg tablets) in healthy Chinese male subjects. This single-dose, open-label, randomized, four-way replicate study with a 1-week washout period was conducted in 60 healthy Chinese male volunteers under fasting conditions. Blood samples were collected over a 12-h period after a single dose of the 25-mg ...

OBJECTIVE This study assessed relative bioavailability of a new subcutaneous formulation, test (T) (dalteparin sodium 95000 IU/3.8 mL) with the branded product (R) in healthy subjects to meet the regulatory requirements of bioequivalence in the US. METHODS This was an open label, randomized, single dose, two-sequence, two-period cross-over study under fasting conditions. A total of 88 healthy...

Introduction. A fixed dose combination of telmisartan and hydrochlorothiazide is indicated for treatment in the arterial hypertension. The these substances causes an additive effect that helps to reduce blood pressure. bioequivalence study Telzap ® Plus compared with MikardisPlus was conducted 63 volunteers. Aim. purpose trial a comparative pharmacokinetics evidence drug product (tablets 80 mg ...

BACKGROUND Ciclosporin is a selective immunomodulator used for the treatment of atopic dermatitis in dogs. A new 100 mg/ml oral solution formulation (Cyclavance®, Virbac) was developed as a pharmaceutical equivalent to the marketed capsule formulations (Atopica®, Novartis Animal Health) containing 25, 50 mg, or 100 mg of ciclosporin A. The aim of this study was to assess and compare the pharmac...

OBJECTIVE This study aims to compare the pharmacokinetics and oral bioavailability of a capsule combining 17β-estradiol and progesterone in a non-peanut oil-containing formulation with those of widely used and approved separate formulations of estradiol and progesterone coadministered to healthy postmenopausal women. METHODS This was an open-label, balanced, randomized, single-dose, two-treat...