Developing drugs for resistant pathogens: Problems and possibilities

2/25/02


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Table of Contents

Developing drugs for resistant pathogens: Problems and possibilities

Acknowledgements

Overview

Selected resistant bacteria of public health concern: 2002

Antibiotic resistance: Prevalence and incidence estimates

Gram-Positive Resistance - United States, 1980-1999

Responses to resistance - PHS Action Plan

Regulatory tools

Regulatory Initiatives

Regulatory Initiatives

Regulatory Initiatives

Sponsor considerations in drug development

U.S. prescription drug sales, 2000

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Feasibility considerations

Categories for drugs active against resistant pathogens

General considerations for focused development

Characteristics of candidate agent for focused development

Risk vs. benefit

Development program - Phase I

Development program - Phases II - III

Data requirements

Traditional vs. focused anti-infective development

Challenges

Summary

PPT Slide

Author: CDER.USER