Bioavailability of psychotropic drugs: historical perspective and pharmacokinetic overview

The evolution of the federal government's role in the regulation and evaluation of generic psychotropic medications is described. To place many of the methodologic bioequivalence issues for antipsychotic agents into perspective, the pharmacokinetics of these drugs are reviewed. Appropriate methodologies for studying the pharmacokinetics and pharmacodynamics of psychotropic drugs are in early developmental stages. Many of the issues relating to bioequivalence of generic products will not be resolved until a better understanding of these factors is developed.