Guidance for Industry No. 204: Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals.

摘要

This guidance document advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness to support product approval for new animal drugs used in cats, dogs, and horses (i.e., companion animals). This guidance document is directed at clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles. In this document, CVM compares studies that use active controls to studies that use either placebo concurrent controls or untreated concurrent controls. CVM uses these comparisons to illustrate the appropriate use of an active control.