ABSTRACT
This chapter will focus on the conduct of veterinary Good Clinical Practice (GCP) trials in poultry that are required for the efficacy evaluation of new drugs or biologics. Poultry trials must be conducted with adherence to the regulations and guideline standards established by government regulatory agenctes. The focus in this chapter will be on U.S. regulations and guidelines as they relate to the proper conduct of GCP trials in poultry. The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) recently published a final rule in the Federal Register titled H Adequate and Well-Controlled Studies for Investigational Use and Approval of New Animals Drugs" (FDA 1998). The stated purpose of this final rule is as follows:
The primary purpose of conducting adequate and wellcontrolled studies of a new animal drug is to distinguish the effect of the new animal drug from other influences, such as spontaneous change in the course of the disease, normal animal production performance, or biased observation. One or more adequate and well-controlled studies are required to establish, by substantial evidence, that a new animal drug is effective.
