Metrics for the evaluation of bioequivalence of modified-release formulations

Laszlo Endrenyi, Laszlo Tothfalusi

Research output: Contribution to journalReview article

23 Citations (Scopus)

Abstract

Metrics are discussed which are used for the evaluation of bioequivalence of modifiedrelease formulations. In order to ensure the therapeutic equivalence of the compared drug products, it would be important to contrast measures which are additional to area under the curve (AUC) and Cmax. For delayed-release products, the assessment of lag times is informative. For extended-release dosage forms, comparisons of the half-value duration and the midpoint duration time are useful. For some modified-release formulations with complicated, multiphasic concentration profiles, the comparison of partial AUCs is important. In determinations of the bioequivalence of extended-release dosage forms, investigations performed under steady-state conditions rather than after single dosing can yield enhanced probability of therapeutic equivalence, especially with substantial accumulation of the drug products. In steady-state investigations of bioequivalence, evaluation of the trough concentration and of the peak trough fluctuation is informative.

Original languageEnglish
Pages (from-to)813-819
Number of pages7
JournalAAPS Journal
Volume14
Issue number4
DOIs
Publication statusPublished - Dec 1 2012

Keywords

  • Bioequivalence
  • Metrics
  • Modified release
  • Steady state
  • Therapeutic equivalence

ASJC Scopus subject areas

  • Pharmaceutical Science

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