Assessing individual bioequivalence using the structural equation model.
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.
Carrasco
Josep-Lluís
JL
Bioestadística, Departament de Salut Pública, Universitat de Barcelona, Barcelona, Spain. carrasco@medicina.ub.es
Jover
Lluís
L
D001682:Biological Availability; D002121:Calcium Channel Blockers / Q000592:standards / Q000627:therapeutic use; D004341:Drug Evaluation / Q000379:methods*; D006801:Humans; D008954:Models, Biological; D015233:Models, Statistical; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards; D014700:Verapamil / Q000592:standards / Q000627:therapeutic use
D002121:Calcium Channel Blockers; D014700:Verapamil