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An FDA perspective on general pharmacology studies to determine activity and safety
Author(s) -
Green Martin D.
Publication year - 1995
Publication title -
drug development research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.582
H-Index - 60
eISSN - 1098-2299
pISSN - 0272-4391
DOI - 10.1002/ddr.430350308
Subject(s) - clinical pharmacology , safety pharmacology , pharmacology , molecular pharmacology , systems pharmacology , broad spectrum , drug , perspective (graphical) , function (biology) , medicine , biology , chemistry , receptor , computer science , combinatorial chemistry , artificial intelligence , evolutionary biology
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. © 1995 Wiley‐Liss, Inc.