Progress on Developing Endpoints for Registrational Clinical Trials of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infections: Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health-Reference-Cited by-同舟云学术

Progress on Developing Endpoints for Registrational Clinical Trials of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infections: Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health

Published:2012-06-28 Issue:8 Volume:55 Page:1114-1121
ISSN:1537-6591
Container-title:Clinical Infectious Diseases
language:en
Short-container-title:

Author:

Talbot George H.¹,Powers John H.²,Fleming Thomas R.³,Siuciak Judith A.⁴,Bradley John⁵⁶,Boucher Helen⁷⁸,

Affiliation:

1. Talbot Advisors, Anna Maria, Florida

2. SAIC-Frederick, in support of the National Institute of Allergy and Infectious Diseases

3. Department of Biostatistics, School of Public Health, University of Washington, Seattle

4. Foundation for the National Institutes of Health, Bethesda, Maryland

5. Department of Pediatrics, School of Medicine, University of California–San Diego

6. Department of Pediatrics, Rady Children's Hospital San Diego, California

7. Tufts Medical Center

8. Tufts University School of Medicine, Boston, Massachusetts

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Link

http://academic.oup.com/cid/article-pdf/55/8/1114/17350469/cis566.pdf

Reference40 articles.

1. Guidance for industry: acute bacterial skin and skin structure infections: developing drugs for treatment;US Food and Drug Administration, Center for Drug Evaluation,2010

2. Guidance for industry: community-acquired bacterial pneumonia: developing drugs for treatment;US Food and Drug Administration, Center for Drug Evaluation,2009

3. Foundation for the National Institutes of Health Biomarkers Consortium Project Team. Recommendations to FDA for interim endpoints for clinical trials in acute bacterial skin and skin structure infections

4. Foundation for the National Institutes of Health Biomarkers Consortium Project Team. Recommendations to FDA for interim endpoints for clinical trials in community-acquired bacterial pneumonia

5. Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugs;Powers;Clin Infect Dis,2007

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