ABSTRACT

The prime purpose of pharmacology experiments designed to demonstrate efficacy (as opposed to safety) is to define the activity of drugs in the indication for which they are intended. It is also useful to have some indication, at least from preclinical efficacy experiments, of the likely efficacious dose in man. This seems a simple enough statement but frequently is more easily said than done. Another basic assumption is that the plasma concentrations of parent compound in the general circulation (a factor that is easily measured) will bear some sort of constant relationship to the final therapeutic effect. This is known as the pharmacodynamic profile of the drug.