FDA Oversight of Cell Therapy Clinical Trials
| Autor: | Celia Witten, Patrick Au, Deborah A. Hursh, Steven S. Oh, Agnes Lim, Bruce S. Schneider, Malcolm Moos |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
medicine.medical_specialty
Cell Transplantation Alternative medicine Pharmacology Risk Assessment Cell therapy Patient safety Risk Factors medicine Humans Intensive care medicine Flexibility (engineering) Clinical Trials as Topic Evidence-Based Medicine United States Food and Drug Administration business.industry Health Policy General Medicine Evidence-based medicine United States Biological Therapy Clinical trial Treatment Outcome Clinical research Research Design Government Regulation Patient Safety Risk assessment business |
| Zdroj: | Science Translational Medicine. 4 |
| ISSN: | 1946-6242 1946-6234 |
| DOI: | 10.1126/scitranslmed.3004131 |
| Popis: | U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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