PHARMACOKINETIC AND PHARMACODYNAMIC STUDIES

University Of California San Francisco, San Francisco CA

Investigators

Linked publications & trials

Abstract

The contractor is to obtain pharmacokinetic and pharmacodynamic information of new medications. Such information is essential for the development of effective pharmacotherapies for the treatment of drug addiction. As medications are often taken with alcohol and/or other drugs, clinical studies shall also be carried out to investigate the nature of the interaction. This project involves recruiting and dosing subjects, collecting biological samples (blood, urine, feces, saliva, hair, sweat, etc.), developing and validating analytical methods, identifying metabolites, quantifying drugs/metabolites in biological samples, monitoring pharmacological responses, and performing statistical, pharmacokinetic and pharmacodynamic analyses of the data. Pharmacokinetic parameters, such as bioavailability, volume of distribution, protein-binding, clearance and half-life shall be determined. The correlation of pharmacological responses with plasma drug level/pharmacokinetic parameters shall be investigated. Specific details for each project (protocol) must be approved by the NIDA Project Officer prior to initiation of each project. All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. The data obtained on the pharmacokinetics and pharmacodynamics of new medications shall be adequate in form and substance for submission to the Food and Drug Administration (FDA) in support of IND and NDA applications.