Aquaculture: 1997 Publications

Author: Greenlees, K.J.
Title: Laboratory studies for the approval of aquaculture drugs.
Publication: Progressive Fish Culturist 59(2):141-148, 1997.
© American Fisheries Society

Notes : All drugs approved by the U.S. Food and Drug Administration (FDA) must be shown to be safe and efficacious. The data required to demonstrate the safety and efficacy of a new animal drug are typically produced through controlled studies conducted by pharmaceutical firms that invest considerable time and money into the process. Factors that have contributed to the paucity of approved drugs for U.S. aquaculture include the relatively limited market for aquaculture drugs and the difficulty involved in conducting studies traditionally carried out in the drug approval process in an aquatic environment. One approach to this problem has been the development of data from other sources. In recent years, government, academic, and private researchers have conducted studies in an attempt to produce the data necessary to satisfy the requirements for the approval of new animal drugs in aquaculture. The data may then be made publicly available and can be used by a sponsor of the drug product to satisfy part of the requirements for the approval of a new animal drug application by the FDA. The studies necessary to demonstrate that a new animal drug is safe and efficacious typically consist of field studies and laboratory studies. Field studies are generally conducted under the control of an investigational new animal drug exemption provided by the FDA. These studies are conducted under the same conditions that would be anticipated under the proposed use of the drug. Laboratory studies may be conducted in traditional indoor laboratories or in less traditional ''laboratory'' ponds or raceways; the common feature of laboratory studies is rigorous control of the experimental conditions. This paper briefly discusses those laboratory studies that are routinely, and perhaps not so routinely, conducted for the approval of a new animal drug in U.S. aquaculture.