PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 12627408

Assessing individual bioequivalence using the structural equation model.

Josep-Lluís Carrasco·Lluís Jover
View original source ↗Export metadata ↓

Abstract

The structural equation model (SEM) is introduced as a useful approach for assessing individual bio-equivalence. SEM parameters are estimated using a partial likelihood analysis and the hypotheses of individual bioequivalence is evaluated in a disaggregate way, testing separately the hypothesis concerning SEM parameters, and assessing the overall hypothesis of individual bioequivalence using the intersection-union principle. Limits of bioequivalence for SEM parameters are proposed and a power analysis is carried out.

Explore related subjects

Biological AvailabilityCalcium Channel BlockersDrug EvaluationHumansModels, BiologicalModels, StatisticalTherapeutic EquivalencyUnited StatesUnited States Food and Drug AdministrationVerapamilComparative StudyJournal Article

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

Josep-Lluís Carrasco, Lluís Jover. 2003-03-30. Assessing individual bioequivalence using the structural equation model.. https://doi.org/10.1002/sim.1452

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2007

Curvature-adjusted optimal design of sampling times for the inference of pharmacokinetic compartment models.

In pharmacokinetics, compartment models are often used to describe the time course of blood concentration after the administration of a drug. In this article, we propose an optimal design criterion for precise estimation of parameters included in the compartment model and illustrate the non-sequential design of sampling times of blood drug concentration data in individual pharmacokinetics. The proposed optimal design criterion minimizes the determinant of the mean-squared error matrix of the parameter estimator that is quadratically approximated by the curvature array. Therefore, the proposed criterion considers the intrinsic and parameter-effects nonlinearity underlying the compartment model, and so is applicable in a pharmacokinetic experiment where the sample size of the blood drug concentration data is quite small.

Biological Availability↗
PubMed2007

Biowaiver monographs for immediate release solid oral dosage forms: isoniazid.

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing isoniazid as the only active pharmaceutical ingredient (API) are reviewed. Isoniazid's solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Isoniazid is "highly soluble" but data on its oral absorption and permeability are inconclusive, suggesting this API to be on the borderline of BCS Class I and III. For a number of excipients, an interaction with the permeability is extreme unlikely, but lactose and other deoxidizing saccharides can form condensation products with isoniazid, which may be less permeable than the free API. A biowaiver is recommended for IR solid oral drug products containing isoniazid as the sole API, provided that the test product meets the WHO requirements for "very rapidly dissolving" and contains only the excipients commonly used in isoniazid products, as listed in this article. Lactose and/or other deoxidizing saccharides containing formulations should be subjected to an in vivo BE study.

Biological Availability↗
PubMed2007

Experimental approaches for studying uptake and action of herbal medicines.

In order to gain wider credibility, herbal medicines must go through the rigorous scientific scrutiny to which synthetic drugs are subjected, and this includes investigating their absorption, bioavailability and metabolism. This review describes approaches for determining how active compounds in herbal formulations enter the systemic circulation. To assess how bioactive molecules enter the target organs and cells, specific cell lines and organ culture models can be used, followed by in vitro models to show how they may regulate digestion, energy balance and metabolism. This could lead to a better understanding of how herbal medicines affect digestion and absorption; fundamental questions which should be answered in addition to their mechanism of action.

Biological Availability↗