Recent experiences with the drug approval process: need and role for drug metabolism data

Some of the problems of obtaining drug efficacy data under field conditions in extensively cultured fish (catfish) are considered. The variable water quality conditions, feeding and management practices encountered in this type of fish culture demonstrate a need for innovative methods to evaluate drug efficacy. Data on drug metabolism and disposition can provide valuable information necessary to evaluate efficacy for the drug regulatory agencies and give the fish producer a better basis for utilizing drugs in fish health management.