The Path to New FDA Guidelines for Clinical Evaluation of Anti-Infective Drugs
| Autor: | Calvin M. Kunin, Thomas R. Beam, D. N. Gilbert |
|---|---|
| Rok vydání: | 1991 |
| Předmět: |
Microbiology (medical)
Gerontology Clinical Trials as Topic medicine.medical_specialty United States Food and Drug Administration business.industry MEDLINE Disease Communicable Diseases United States Food and drug administration Clinical trial Infectious Diseases Clinical research Anti-Infective Agents medicine Humans Anti infectives Intensive care medicine business Clinical evaluation Societies Medical |
| Zdroj: | Clinical Infectious Diseases. 13:S890-S894 |
| ISSN: | 1537-6591 1058-4838 |
| DOI: | 10.1093/clinids/13.supplement_10.s890 |
| Popis: | This article describes the current collaborative effort of the U.S. Food and Drug Administration and the Infectious Diseases Society of America to generate new general and disease/organism-specific guidelines for the evaluation of anti-infective agents. The description includes examples of proposed changes from draft documents. If approved and implemented, the envisioned changes should enable investigators and sponsors to improve the quality of clinical trials of anti-infective drugs. The ultimate goal is to provide physicians with the best information about new drugs and thus to enhance the care of patients with infectious diseases. |
| Databáze: | OpenAIRE |
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