Bioekvivalencia vizsgálat szimulációja kioldódási görbék alapján.

Translated title of the contribution: [Simulation of bioequivalence study on the base of dissolution curves].

Gyula Grezál, L. Vereczkey

Research output: Contribution to journalArticle

Abstract

A computer method based on the in vitro dissolution of drug preparations has been elaborated for the estimation of bioequivalence. The method generates a "dissolutaion surface" from the parameters of time (X-axis), from pH (Y-axis) and from the dissolved amount (A) in % of the drug. This dissolution surface allows the determination of the general dissolution curve of the test and reference preparations. By supposing that the absorption rate constant is known from the literature, the change of the amount of dissolved drug as the function of time can be determined. On the base of this function the maximum amount of the dissolved drug in the gastrointestinal tract and the AUC can be calculated. and the test/reference ratio can be determined. In the case of linear pharmacokinetics these ratios are identical to the ratios of parameters that can be calculated in the circulation. By generating parameters between the allowed biological limits the dissolved drug-time curves of "volunteers" in the necessary number are created with the randomly generated "residence times" and their confidence intervals can be determined, i.e., on the base of dissolution curves bioequivalence can be estimated.

Original languageHungarian
Pages (from-to)55-59
Number of pages5
JournalActa Pharmaceutica Hungarica
Volume82
Issue number2
Publication statusPublished - 2012

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Therapeutic Equivalency
Pharmaceutical Preparations
Drug Compounding
Area Under Curve
Gastrointestinal Tract
Volunteers
Pharmacokinetics
Confidence Intervals

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Bioekvivalencia vizsgálat szimulációja kioldódási görbék alapján. / Grezál, Gyula; Vereczkey, L.

In: Acta Pharmaceutica Hungarica, Vol. 82, No. 2, 2012, p. 55-59.

Research output: Contribution to journalArticle

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