Benefit-Risk Reevaluation of Marketed Drugs

3/19/01


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Table of Contents

Benefit-Risk Reevaluation of Marketed Drugs

FDA Presentations: Themes

FDA Presentations

FDA Presentations

FDA Presentations

Benefits of Lotronex

Benefits of Lotronex: Issues

Benefits of Lotronex: Issues

Limit Lotronex Administration to Target Population

What is the Target Population?

Need for Legitimate Diagnosis of Irritable Bowel Syndrome

Other Populations

Limit Administration of Lotronex to Responders

Lotronex Responders: The Issue

Study 3001: Diarrhea-Predominant Subgroup: Monthly Relief of IBS Pain/Discomfort: LOCF

Study 3002: Diarrhea-Predominant Subgroup: Monthly Relief of IBS Pain/Discomfort: LOCF

Responders: Conclusions

Responders: Conclusions

Benefit: Overall Conclusions

Benefit: Overall Conclusions

Author: Victor Francis Charles Raczkowski