OBJECTIVE To compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants. DESIGN Systematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs. DATA SOURCES Medline and Embase from 1980 to September 2014. REVIEW METHODS A literature search was performed for all studies comparing ...

Introduction: Systemic corticosteroids are anti-inflammatory agents with dexamethasone among the most potent in the class. Within (respiratory) allergy, systemic corticosteroids are usually applied in medical emergencies. In these situations, patients may experience physical or logistic problems taking tablets. To fulfil a practical unmet need for outpatients, Dexa ODF, an oral dissolvable film...

In the past years various approaches for assessing bioequivalence of so-called "highly variable drugs" have been debated. These are drugs whose pharmacokinetic profiles vary considerably when given to the same subject. As a consequence of the high variability, average bioequivalence between two such drugs can only be shown with an unfeasibly high number of subjects. Therefore regulatory agencie...

PURPOSE The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. MATERIALS AND METHODS A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study peri...

Title Average bioequivalence and bioavailability data analysis tool Author Hsin-ya Lee , Yung-jin Lee Maintainer Hsin-ya Lee Description An average bioequivalence (ABE) and bioavailability data analysis tool including sample size estimation, noncompartmental analysis (NCA), ANOVA (lm) for a standard RT/TR 2x2x2 crossover design and...

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...

OBJECTIVE Small levothyroxine (L-T4) dose changes can lead to significant clinical effects. To ensure thyroid hormone levels are safely maintained, authorities are increasingly adopting stricter potency specifications for L-T4, the most stringent of these being 95-105% of the labeled dose over the whole shelf-life. Levothyroxine sodium (Euthyrox, Eutirox, Lévothyrox ) has been reformulated, and...