A proposed design for conducting target animal safety studies for developing new veterinary pharmaceuticals.
Target animal safety studies are required for the regulatory approval of any new veterinary pharmaceutical registered almost anywhere in the world. Both the United States and Europe have extensive guidelines for conducting these studies. Due to new veterinary drug labeling requirements in the United States, changes in the overall design of target animal safety studies will be required for the United States. The guideline changes proposed in this paper are more evolutionary than revolutionary. While many new ideas are suggested, a number of existing practices that seem to work well were retained. Several new abbreviated drug development pathways are also proposed, an idea missing from current guidelines. This proposal, and others like it, should serve as a basis for representatives from the U.S. Food and Drug Administration, the European Commission on Veterinary Medical Products, the veterinary pharmaceutical industry, and practicing veterinarians to develop internationally harmonized target animal safety study guidelines that are clear in their intent, scientifically sound, and practical.
Carakostas
M C
MC
Colaianne
J J
JJ
D000827:Animal Welfare; D000818:Animals; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D004305:Dose-Response Relationship, Drug; D005060:Europe; D017408:Guidelines as Topic; D014116:Toxicology / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration; D014730:Veterinary Medicine / Q000639:trends*