Thomas A. Ban: Psychopharmacology. Baltimore: Williams and Wilkins; 1969

Leon S. Morra’s Extracts 4
Part One, Chapter One: General Principles
B. From chemical synthesis to clinical application

            “The chemical synthesis of a potentially psychoactive substance is followed by animal pharmacological studies, which precede the various stages of human investigations………..These are Human Pharmacology (Phase I), Clinical Pharmacology (Phase II) , and Clinical Investigation (Phase III).”

            “In the course of ‘human pharmacology’ the effects of the experimental substance on the corresponding variables studied in animals are explored in healthy volunteers, whereas in ‘clinical pharmacology’ the action of the new drug on psychopathological symptoms and their psychological, psychophysiological, neurophysiological and neurochemical correlates are investigated. Finally verification of the data in the clinical investigation.”

            “Prior to any ‘human studies’ with a new drug there are a number of legal and ethical aspects to consider.”


León S. Morra

March 2, 2017