Scientific Publications by FDA Staff

Drug Dev Res 1995 Jul;35(3):158-60

An FDA perspective on general pharmacology studies to determine activity and safety

Green MD

General pharmacology studies are conducted to determine various pharmacological activities, as part of drug discovery or to define some specific issues which are relevant to safety. Regulatory submissions of biological products, unlike other therapeutics classes of agents, e.g., drugs, are frequently accompanied by extensive information regarding their preclinical aspects of physiology, biochemistry, and pharmacology. Although not true in every instances, biologic products exert their effects in a highly specific manner. Various fundamental aspects of protein chemistry and receptor function combine to restrict the spectrum of pharmacological and toxicological effects likely to occur. General pharmacology studies may be conducted either separately or nested in larger studies assessing general toxicity. Pharmacology studies are used best in an attempt to answer specific questions and are particularly effective when complementing other tests of safety.