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IDSA/PhRma/FDA Working Group Meeting
November 19-20, 2002
IDSA/PhRma/FDA Working Group Mtg. Presentations:
- Clinical
Trials of Anti-Infectives for Highly Resistant Microorganisms by
Richard P. Wenzel, M.D., M.Sc.
- Drug
Development for Resistant Pathogens by Francis P. Tally, M.D.
- Developing
Drugs for the Treatment of Infections due to Resistant Pathogens
by Edward Cox, M.D., M.P.H.
- Use of PK/PD
to Facilitate Development of Drugs for Treatment of Resistant
Pathogens by William A. Craig, M.D.
- Use of PK/PD
to Facilitate Development of Drugs for Treatment of Resistant
Pathogens by James A. Poupard, Ph.D.
- Exposure-Response:
Application to Antimicrobial Drug Development by Philip Colangelo,
Pharm.D., Ph.D
- Antibiotic
Resistance: Incentives for Antimicrobial Development by Mark J.
Goldberger, M.D., M.P.H.
- Incentives
in Drug Development Biotech View by Frank Tally, M.D.
- Regulatory
and Other Incentives for Antibiotic Development by David M.
Cocchetto, Ph.D.
- Issues
regarding non-Inferiority margins in Clinical Trials by George H.
Talbot, M.D.
- Non-Inferiority
Margins: Implications, Challenges, and Opportunities by Christy
Chuang-Stein, Ph.D.
- Issues
in Selection of Deltas in Non-Inferiority Trials by John H.
Powers, M.D.
- Bacterial
Meningitis by John S. Bradley, M.D.
- Clinical
Trials in Acute Bacterial Meningitis by Roger M. Echols, M.D.
- Antimicrobial
Drug Development for Acute Bacterial Meningitis by Imo Ibia, M.D.,
M.P.H.
- Are
Antibiotics Useful in Exacerbations of Chronic Bronchitis? by JV
Hirschmann, M.D.
- Clinical
Trials in AECB by Roger M. Echols, M.D.
- Acute
Exacerbation of Chronic Bronchitis - Issues in Drug Development by
Susan D. Thompson, M.D.
- Healthcare-Associated
Pneumonia (HAP): Issues for Clinical Trials by Donald E. Craven,
M.D.
- Issues
in Antibacterial Clinical Trials for Nosocomial Pneumonia by
Richard Gesser, M.D.
- Hospital Acquired Pneumonia (HAP) by Sary
Beidas, M.D.
These presentations are in Microsoft PowerPoint format. If you do
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a free viewer.
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Presentations
FDA/Center for Drug Evaluation and Research
Last Updated: December 11, 2002
Originator: OTCOM/DLIS
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