Selection of D in Clinical Trials of Antimicrobial Therapy - Acute Exacerbation of Chronic Bronchitis

2/25/02


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Table of Contents

Selection of D in Clinical Trials of Antimicrobial Therapy - Acute Exacerbation of Chronic Bronchitis

Acute Exacerbation of Chronic Brochitis (AECB) - Outline

AECB

AECB

PPT Slide

AECB - Definition

Selection of D for Clinical Trials

Selection of D - AECB

AECB - Current FDA Guidance

AECB - Approach to determination of D1

AECB - Placebo controlled trials: Anthonisen, et al

AECB - Placebo controlled trials: Anthonisen, et al (2) “Winnipeg criteria”

AECB - Placebo controlled trials: Anthonisen, et al (3)

AECB - Placebo controlled trials: Anthonisen, et al (4)

AECB - Placebo controlled trials: Anthonisen, et al (5)

AECB - Placebo controlled trials: Saint, et al

AECB - Placebo controlled trials: Saint, et al (2)

AECB - Placebo controlled trials: Saint, et al (3)

AECB - Placebo controlled trials: Saint, et al (4)

AECB - Placebo controlled trials: Allegra, et al

AECB - Placebo controlled trials: Bach, et al

AECB - Placebo controlled trials: Nouira et al

AECB - Placebo controlled trials: Agency for Healthcare Research and Quality(AHRQ)

AECB - Placebo controlled trials: AHRQ (2)

AECB - Placebo controlled trials: AHRQ (3)

Confounding Issues in AECB Trials

Confounding Issues in AECB Trials

AECB study populations

AECB - “Old” versus “new” antibiotics

AECB - Can D1 be determined?

AECB - Selection of D

Conclusions

AECB - Options for Future Trials

AECB - Options for Future Trials

AECB - Unresolved Issues

Author: CDER.USER