Abstract

There are currently very few FDA approved drugs for use in fish, primarily due to the high cost of conducting the research to obtain the data required for drug approval. One strategy recommended to reduce costs is to define species groups for particular studies, such as the human food safety evaluation. A large amount of supportive data, however, must be compiled in order to demonstrate that information from a model species will accurately predict the responses of all the members of a group. Compared to mammals, there is a general lack of the literature describing drug depletion or pharmacokinetic studies in fish. Certainly there are a few fish species, channel catfish and salmonids, which dominate the literature. As part of CVM/FDA's commitment to streamlining the drug approval process for minor species, we have begun to develop a database of literature detailing drug metabolism, depuration and pharmacokinetics in multiple fish species. This current database consists of over 150 articles which include data from 50 species (40 genera) of fish. Data fields include genus species, water temperatures, the average animal weight, sample types analyzed, drug name, dosage, route of administration, metabolites identified, protein binding, clearance, volume of distribution in a central compartment (Vc) or volume of distribution at steady state (Vd) and drug half-lives (t ½). Additional fields list the citation, authors, title, and internet links. This database will be a valuable resource to investigators of drug metabolism in aquatic species as well as government and private organizations involved in the drug approval process for aquatic species.