ABSTRACT
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.
Subject(s)
Drug Evaluation/methods , Models, Biological , Models, Statistical , Therapeutic Equivalency , Biological Availability , Calcium Channel Blockers/standards , Calcium Channel Blockers/therapeutic use , Humans , United States , United States Food and Drug Administration/standards , Verapamil/standards , Verapamil/therapeutic useSubject(s)
Verapamil/standards , Humans , Tablets , Therapeutic Equivalency , Verapamil/pharmacokineticsABSTRACT
Potentialities of the non-invasive method of trans-esophagus electrostimulation of the heart were studied with regard to the selection and assessment of the effectiveness of antiarrhythmic therapy in 16 patients with paroxysms of supraventricular reciprocal tachycardia. The antiarrhythmic therapy selected by this method proved effective in 13 patients following a prolonged course of treatment. The method was highly informative in predicting the efficacy of the systemic course treatment of patients with supraventricular tachycardia paroxysms.
