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1983 Symposium Proceedings
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Special Sympsium (1983) Proceedings

Entire proceedings - (9,136 KB) 

Table of Contents 

Proceedings by section: 

Section I: Fundamental Legal, Statistical, Industrial, and Regulatory Bases for Dose Determination 

Interface of FDA product decisions and science, Terry Harvey
Clinical dose determination, Dwight Mercer
The impact of dose determination on development of animal drugs, Rainer Muser 
Discussion 
What is statistical significance in dose determination? Jean Powers
What is an adequate base for dose determination?Daniel Gingerich
Dose determination: what is substantial evidence? T. Jefferson Murphy 
Discussion 

Section II: Pharmacological Basis of Dose Determination of Antimicrobial Drugs 

The value and limitation of pharmacokinetics in predicting dosage regimens 

Richard Teske
Gary Koritz
J. Edmund Riviere 

Comments on pharmacokinetics 

Stephen Bai
Jerry Brunton 

Some scientific bases used in extrapolation, Thomas Powers
Human food safety aspects of dose determination, Robert Livingston 
Discussion 

Section III: Experimental Design of Dose Determination Studies with Antimicrobial Drugs 

Use of clinical trials for dose determination 

Thomas Keefe
Harlan Bigbie
Wally Brandt 

Comments on clinical trials 

Donald Gable
Lloyd Davis 
Discussion 

Use of animal models for dose determination of antimicrobial drugs 

Donald Campbell
Robert Furrow
Jerry Ling
George Gunderson 

Comments on animal models 

James Colaianne
William Jenkins 
Discussion 

The future for dose determination, Robert Baldwin 

Task Force Report and Recommendations

 

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