The role of clinical pharmacology in supporting the emergency use Authorization of an unapproved anti-influenza drug, peramivir

Clinical Pharmacology and Therapeutics

Volumn 88, Issue 5, 2010, Pages 587-589

  Arya, V ^a   Carter, W W ^a   Robertson, S M ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

OSELTAMIVIR; PERAMIVIR; PLACEBO; SIALIDASE INHIBITOR; ZANAMIVIR; ANTIVIRUS AGENT; CYCLOPENTANE DERIVATIVE; ENZYME INHIBITOR; GUANIDINE DERIVATIVE; SIALIDASE;

AREA UNDER THE CURVE; CHRONIC KIDNEY FAILURE; CLINICAL PHARMACOLOGY; CLINICAL TRIAL; CONTINUOUS HEMOFILTRATION; CONTINUOUS RENAL REPLACEMENT THERAPY; DIARRHEA; DRUG APPROVAL; DRUG CLEARANCE; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG SAFETY; DRUG USE; EMERGENCY TREATMENT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEMODIALYSIS; HOSPITAL PATIENT; HUMAN; INFLUENZA A (H1N1); KIDNEY DYSFUNCTION; KIDNEY FAILURE; LEUKOCYTE COUNT; LOADING DRUG DOSE; NAUSEA; NOTE; PANDEMIC INFLUENZA; PEDIATRICS; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SINGLE DRUG DOSE; TREATMENT OUTCOME; VOMITING; ADOLESCENT; ADULT; ANTAGONISTS AND INHIBITORS; CHILD; DRUG EFFECTS; EMERGENCY HEALTH SERVICE; ENZYMOLOGY; EVIDENCE BASED MEDICINE; GOVERNMENT REGULATION; HEALTH CARE POLICY; HOSPITALIZATION; INFANT; INFLUENZA VIRUS A H1N1; INFLUENZA, HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LEGISLATION AND JURISPRUDENCE; NEWBORN; PATHOGENICITY; PRESCHOOL CHILD; RISK ASSESSMENT; UNITED STATES; VIROLOGY;

ADOLESCENT; ADULT; ANTIVIRAL AGENTS; CHILD; CHILD, PRESCHOOL; CYCLOPENTANES; DRUG APPROVAL; EMERGENCY MEDICAL SERVICES; ENZYME INHIBITORS; EVIDENCE-BASED MEDICINE; GOVERNMENT REGULATION; GUANIDINES; HEALTH POLICY; HOSPITALIZATION; HUMANS; INFANT; INFANT, NEWBORN; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; INJECTIONS, INTRAVENOUS; NEURAMINIDASE; RISK ASSESSMENT; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77958476873     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.187     Document Type: Note

References (5)

1. US Food and Drug Administration.Guidance\-Emergency Use Authorization of Medical Products (July 2007).
2. US Food and Drug Administration. Peramivir Emergency Use Authorization Disposition Letter and Question and Answer Attachment (22 June 2010).
3. Birnkrant, D. & Cox, E. The Emergency Use Authorization of peramivir for treatment of 2009 H1N1 influenza. N. Engl. J. Med. 361, 2204-2207 (2009).
4. US Centers for Disease Control and Prevention. Fact Sheet for Healthcare Providers for the Emergency Use Authorization of Peramivir (2009).
5. US Food and Drug Administration. Questions and Answers for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV (2010). http://www.fda.gov/Drugs/ DrugSafety/Postmarket DrugSafetyInformationforPatientsand Providers/ucm187709.htm