Evaluating average bioequivalence using methods for high variability drugs: A case study

Sanchez, MP; Gómez C; Carrasco, JL; Ocana, J; Von Plessing, C; Godoy, CG; Reinbach, R; Godoy, R

Abstract

The purpose of this study was to determine if different methods for average bioequivalence in high variability drugs coincide or not in their conclusions when applied to the same dataset, and to discuss the method validity and reliability of the conclusions. Different approaches for the evaluation of average bioequivalence were applied to the results of a bioavailability trial on the diuretic drug Furosemide. These methods included widening the bioequivalence limits according to regulatory recommendations, scaling the limits and scaling the bioequivalence statistic, jointly with evaluating alternative bioavailability measures. The methods to establish the bioequivalence limits were also combined with some alternative methods to construct confidence intervals. The decision on bioequivalence depends much more on the bioavailability measures than on the statistical approach. The reliability of the final decision lies mainly in the interpretation of these measures and on the special characteristics of each drug. © 2008 Dustri-Verlag Dr. K. Feistle.

Más información

Título según WOS: Evaluating average bioequivalence using methods for high variability drugs: A case study
Título según SCOPUS: Evaluating average bioequivalence using methods for high variability drugs: A case study
Título de la Revista: International Journal of Clinical Pharmacology and Therapeutics
Volumen: 46
Número: 10
Editorial: Dustri-Verlag Dr. Karl Feistle
Fecha de publicación: 2008
Página de inicio: 527
Página final: 537
Idioma: English
Notas: ISI, SCOPUS