COMPUTERIZED RESOLUTION OF PHARMACOKINETIC DATA FROM PHYSIOLOGICAL SIGNALS

JAMES MERL CLEVENGER, Purdue University

Abstract

Methods were developed using a digital computer to analyze the effects of the phenothiazine antipsychotic drugs on the EEG and EKG signals. From the results of these signal analysis methods, variables were determined that would show the time course of changes in the EEG and EKG signals. These methods were applied to two studies. First, the methods were applied to a pilot bioavailability study to determine if the EEG and the EKG signals could be used to evaluate the performance of drug products. In this study four doses of trifluoperazine oral concentrate (Stelazine('R)) were given to four subjects in a Latin Square experimental design. Second, the methods were applied to a perphenazine bioequivalence study to determine if two 8 mg Trilafon('R) tablets are bioequivalent to two 8 mg Trilafon('R) Repetabs. The results indicated that changes did occur in the EEG and EKG signals and that variables could be found that would reflect the time course of the drug effects on those signals. From the variables, information was extracted that indicated the rate and extent of the drug effects on the pharmacological responses.

Degree

Ph.D.

Subject Area

Pharmaceuticals

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