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Special Symposium (1985) Proceedings
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Special Symposium (1985) Proceedings

Entire proceedings - (7,535 KB) - Clinical Trials with Therapeutic Drugs in Animals 

Table of Contents 

Proceedings by session: 

Session I: Clinical Trials - the Issues 

Bob Griffith: Perspectives from FDA
Daniel Gingerich: Perspectives from industry
Charles Vail: Perspectives from practice
Lloyd Davis: Perspectives from academia
Discussion
Lloyd E. Davis and William W. Muir: Potential role of the veterinary medical teaching hospitals in the evaluation of new drugs
Thomas E. Powers and Jean D. Powers: Organization and function of the veterinary clinical pharmacology study unit
Discussion 

Session II: Clinical Trials - Experimental Design 

Jean Powers and Thomas E. Powers: Statistical view of clinical trials: academia
James Colaianne: Statistical view of clinical trials: FDA
Robert Rathmacher: Statistical view of clinical trials: industry
Discussion
Thomas Keefe: Considerations in designing protocols for antimicrobial drugs
Terence Harvey: Clinical trials with physiological drugs: requirements, results, and claims
Stirling Dawley: Experimental designs for clinical studies with anti-inflammatory drugs
Rainer Muser: Clinical trials with anthelmintics
Discussion
Charles Francis: Classification of over-the-counter and prescription drugs
Gene Swenson: Experimental design of clincial trials with combination drugs
E. Wynn Jones: Integration of clinical trials
Discussion
Report and discussion of practitioner/clinician workshop to symposium 

Session III: Clinical Studies: Management and Evaluation of Performance 

William Kay: Clinical studies: the investigator's responsibilities
James Rourke: Clinical monitoring: the sponsor's responsibility
Richard Carnevale: Clinical trials: responsibility of FDA/CVM
Discussion
Arthur Aronson and Jim Riviere: Role of therapeutic drug monitoring in the design and execution of clinical trials
Task Force Report and Recommendations

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