Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical-driven balance of population average and variability.

Autor: Soufsaf S; Université de Montréal, Montréal, Québec, Canada., Nekka F; Université de Montréal, Montréal, Québec, Canada., Li J; Université de Montréal, Montréal, Québec, Canada.
Jazyk: angličtina
Zdroj: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2022 Apr; Vol. 11 (4), pp. 482-493. Date of Electronic Publication: 2022 Mar 18.
DOI: 10.1002/psp4.12775
Abstrakt: Among the current approaches for the analysis of bioequivalence, the average bioequivalence (ABE) is limited only to the mean bioavailability, whereas the population bioequivalence (PBE) criterion aggregates both mean and variance in a general comparison formula. However, a rational bioequivalence criterion capable of judging specific drug considerations is always still preferred. As an alternative approach, we introduce an aggregate criterion, namely, the trapezoid bioequivalence (TBE), which includes the consideration of both mean and variance of the bioavailability and adapted weighting of a drug's therapeutic properties. We first applied our method to specific simulated scenarios to compare the strengths and weaknesses of current bioequivalence approaches and demonstrate the improvements brought by TBE. As well, the impact of sample size and variability on ABE, PBE, and TBE are assessed using a population pharmacokinetic model of methylphenidate. Our results indicate that TBE inherits the advantages of both ABE and PBE while greatly reducing their inadequacies. Through simulations with population pharmacokinetic models of specific scenarios, we confirm that (1) TBE does not encounter the overly permissiveness issue of PBE, (2) TBE respects the hierarchy to ABE (TBE => ABE), and (3) TBE assesses bioequivalence with a restriction on σ T 2 - σ R 2 without an increase to type 2 errors. The clinically inspired simulations demonstrate TBE's superiority in a realistic context and its potential usefulness in practice. Moreover, the parameter choice in TBE may be adapted according to the specific context of a drug's pharmacological and pharmacodynamic properties.
(© 2022 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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