Special Symposium (1985) Proceedings
The proceedings are now available:
- Entire proceedings - (7,535 KB) - Clinical Trials with Therapeutic Drugs in Animals
- Table of Contents
- Proceedings by session:
- I: Clinical Trials - the Issues
- Perspectives from FDA, Bob Griffith
- Perspectives from industry, Daniel Gingerich
- Perspectives from practice, Charles Vail
- Perspectives from academia, Lloyd Davis
- Discussion
- Potential role of the veterinary medical teaching hospitals in the evaluation of new drugs, Lloyd E. Davis and William W. Muir
- Organization and function of the veterinary clinical pharmacology study unit, Thomas E. Powers and Jean D. Powers
- Discussion
- II: Clinical Trials - Experimental Design
- Statistical view of clinical trials: academia, Jean Powers and Thomas E. Powers
- Statistical view of clinical trials: FDA, James Colaianne
- Statistical view of clinical trials: industry, Robert Rathmacher
- Discussion
- Considerations in designing protocols for antimicrobial drugs, Thomas Keefe
- Clinical trials with physiological drugs: requirements, results, and claims, Terence Harvey
- Experimental designs for clinical studies with anti-inflammatory drugs, Stirling Dawley
- Clinical trials with anthelmintics, Rainer Muser
- Discussion
- Classification of over-the-counter and prescription drugs, Charles Francis
- Experimental design of clincial trials with combination drugs, Gene Swenson
- Integration of clinical trials, E. Wynn Jones
- Discussion
- Report and discussion of practitioner/clinician workshop to symposium
- III: Clinical Studies: Management and Evaluation of Performance
- Clinical studies: the investigator's responsibilities, William Kay
- Clinical monitoring: the sponsor's responsibility, James Rourke
- Clinical trials: responsibility of FDA/CVM, Richard Carnevale
- Discussion
- Role of therapeutic drug monitoring in the design and execution of clinical trials, Arthur Aronson and Jim Riviere
- Task Force Report and Recommendations
- I: Clinical Trials - the Issues