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
PPT Slide
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
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