Bioequivalence testing aims to ensure that the therapeutic performance of drug is consistent and reproducible when it administrated. Modeling simulation in silico methods are currently performed conduct virtual bioequivalence studies. Various computer software used generate model input data. This review summarizes for predicting vivo which supports analysis testing. GastroPlus™ SimCyp® widely p...

Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products. In this study, we sought to systematically assess the current trends of ongoing and recently completed bioequivalence and bioavailability trials that have been registered within a nation...

The purpose of this article is to explicate the procedures for detecting outliers subject in bioequivalence study as per as per various regulatory agencies (e.g. USFDA, TPD, ANVISA and CDSCO). The existence of outlier subjects in bioequivalence studies possibly will have an effect on the results of the study. The present article provides the details regarding Studentized Residual Test and Lund ...

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...

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...

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...