established practitioner, offering alternative ways of conducting clinical trials that are in compliance with regulations. A global panel of experts shares its experiences in clinical studies involving all of the major species.
Introduction and Overview of Setting Up Studies to Good Clinical Practice. International Harmonization and the Conduct of Clinical Studies to Support the Approval of New Animal Drugs: The U.S. Perspective. The Role of the Investigator. The Role of the Monitor. Quality Assurance on Veterinary Clinical Trials. Setting Up GCP Trials in Fish. Setting GCP Trials in Poultry. Setting Up GCP Trials in Companion Animals. Setting Up GCP Trials in Pigs. Setting Up GCP Trials in Calves. Setting Up GCP Trials in Sheep. Setting Up GCP Trials in Horses and Ponies. Genetically Modified Micro-Organisms and GCP Studies. Contract Research Farms and Their Involvement with GCP Studies. The Practicing Veterinarian's Role in Clinical Trials. Standard Operating Procedures. The Generic Protocol. How to Write the Final Study Report. Data, Statistical Analysis and Reporting for Veterinary Clinical Trials. Registration Submissions for Veterinary Medicines. Large-Scale Production of Ectoparasites for Use in Veterinary Trials. Auditing GCP Trials. Multisite Studies. Appendices. Index.
