ABSTRACT

As such, GCP contributes to the achievement of the goals of a clinical trial. Essentially, clinical trials provide information on the efficacy and tolerability of the test product under typical field conditions. Data produced must be carefully controlled and of high quality so as to be useful for registration and marketing purposes within the animal health industry. As such, trials are undertaken both before and after Marketing Authorisation, and similar studies will eventually become included under the extended scope of pharmacovigilance.