Antibiotic Development Strategies to Understand and Label Microbial Endpoints such as Slow killing, resistance and Failure, AUIC Dosing and Success via Synergy

2/25/02


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Table of Contents

Antibiotic Development Strategies to Understand and Label Microbial Endpoints such as Slow killing, resistance and Failure, AUIC Dosing and Success via Synergy

Introduction

PK/PD: AUIC and Selected Resistance

PK/PD trials of Antibiotics

PPT Slide

MRSA: Issues With Appropriately Dosed Vancomycin?

Comparison of Vancomycin days to eradication for MRSA Infections

Study Design Issues

Strategies for MRSA failing vancomycin after 5 days Tx

PPT Slide

In Vivo Synergy: Quinupristin/Dalfopristin Plus Vancomycin Against MLSBC Strains of MRSA for Endocarditis*

Vancomycin Failure Study

Outcomes

14 Day (% Culture Positive)

PPT Slide

PK/PD

Micro Cure as a Surrogate?

PPT Slide

Clinical Trials are Designed to Assure Equivalence....

ABX Equivalence vs Superiority

Delta, power and sample size on a dichotomous vs continuous endpoint

Alternative View from the Front

Recommendations

Disclosures - J.J. Schentag

Author: Jerome J Schentag