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
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