Special Sympsium (1983) Proceedings
The proceedings are now available:
- 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
- Comments on pharmacokinetics
- 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
- Comments on clinical trials
- Discussion
- Use of animal models for dose determination of antimicrobial drugs
- Comments on animal models
- Discussion
- The future for dose determination, Robert Baldwin
- Task Force Report and Recommendations
- Section I: Fundamental Legal, Statistical, Industrial, and Regulatory Bases for Dose Determination
