ABSTRACT
The study of the metabolism of foreign compounds in mammalian systems began as long ago as the 19th century with the discovery of pathways of conjugation and aryl and alkyl hydroxylation. During the next hundred years major advances were made in various laboratories which provided the necessary background against which industrial pharmaceutical companies built their present approaches to drug metabolism studies. Some companies were already active in this area by the 1960s, but it was not until 1968, when the thalidomide tragedy had led to a general tightening up of regulatory requirements of new drugs, that the U.S. government declared its objective of requesting metabolic data prior to licensing new drug products, a move which was followed by regulatory authorities around the world.
