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...

June 29, 2010 Version 2.5.3 Date 2010-06-25 Title Average bioequivalence and bioavailability data analysis tool Author Hsin-ya Lee, Yung-jin Lee Maintainer Yung-jin Lee Depends R (>= 2.10.0), reshape, nlme, sciplot, plotrix, ICSNP, gdata Description An average bioequivalence (ABE) and bioavailability data analysis tool including sample size estimation, noncompartmental anal...

the objective of the present study was to evaluate the pharmacokinetic parameters and bioavailability of a selective histamine (h1)-receptor antagonist, cetirizine hydrochloride (ctz), following administration of a single oral dose of the drug. the properties of a test compound were compared with those of a reference product in a randomized cross-over study in 12 volunteers. blood samples were ...

background: imatinib is known as the drug of choice for treatment of chronic myeloid leukemia (cml). for adults the recommended daily dosage of 400 mg requires simultaneous intake of up to four capsules or tablets each 100 mg. a new 400 mg film coated tablet developed due to the need to swallow multiple capsules or tablets per dose and that was a negative impact on treatment adherence. subjects...

    In this double blind crossover study we assessed the bioequivalence of 200 mg enteric coated sodium valproate tablets manufactured by Roozdarou with 200 mg enteric coated sodium valproate (Orlept) manufactured by Desitin, Germany. Twelve healthy male volunteers were administered a single dose of 600 mg sodium valproate manufactured by Roozdarou, followed by a similar dose of Orlept, 2 weeks...

Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy...

The statistical test for population bioequivalence given in the current FDA guidance document on this matter ignores the dependence between summary statistics. It is very conservative in cases where there is a high degree of correlation of subject responses between test and reference formulations, which is usually the case in bioequivalence studies. Adapting the ideas of Kass and Wolfinger (200...

The US Food and Drug Administration has recommended statistical guidelines that introduce two new bioequivalence criteria: population bioequivalence (PBE) and individual bioequivalence (IBE). In this paper we propose a hierarchical Bayesian methodology for evaluating these recently introduced criteria. We derive the joint posterior distribution of the parameters involved in a crossover design a...

The population bioequivalence of two measurements is considered via diierentiable statistical functionals. This approach leads to eecient nonparame-tric bioequivalence tests given by the canonical gradient of the functional. The results are based on an asymptotic comparison of nonparametric power functions of rank tests. The bioequivalence regions are determined by implicit alternatives speciie...