title: Good laboratory practice considerations in the use of fish models.
abstract: In the late 1970's, Good Laboratory Practice Regulations (GLP) were instituted by agencies such as the USFDA, the USEPA, and the OECD to provide a system for the monitoring of animal studies submitted in support of the safety of regulated products. Although GLP regulations are regularly employed in laboratory mammal projects, they have been comparatively under-utilized in aquatic animal research. This situation is changing due to the continuing emergence of fish as toxicological and pharmaceutical test subjects, human and animal disease models, genetically-engineered food sources, and environmental sentinels. The application of GLP principles to aquatic animal studies poses a variety of challenges, especially in the areas of Study Protocol design and the creation of Standard Operating Procedures (SOP's). This presentation will highlight differences between mammalian and fish studies in the application of GLP principles, and identify specific concerns associated with the formulation of SOP's for fish projects.
authors.affiliation: Experimental Pathology Laboratories, Inc, Sterling, Virginia 20166, USA. jwolfepl@aol.com
authors.forename: Jeffrey C
authors.initials: JC
authors.lastname: Wolf
authors.forename: Marilyn J
authors.initials: MJ
authors.lastname: Wolfe
mesh_terms: D000818:Animals; D019411:Clinical Laboratory Techniques / Q000592:standards*; D005399:Fishes; D006799:Housing, Animal / Q000592:standards; D023421:Models, Animal; D011786:Quality Control; D012106:Research / Q000331:legislation & jurisprudence / Q000592:standards*; D012107:Research Design; D014116:Toxicology / Q000379:methods / Q000592:standards