Expanded Distribution of an Investigational Drug in Parallel with Ongoing Controlled Clinical Trials: The Didanosine Model

The purpose of the didanosine Expanded Access Program was to provide a needed antiretro-viral agent to individuals who were unable to tolerate other therapy for human immunodeficiency virus infection or in whom such therapy was failing. The logistics of establishing this program are described, and t...

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Veröffentlicht in:	Clinical infectious diseases 1994-12, Vol.19 (6), p.1071-1075
Hauptverfasser:	Pike, Isadore M., Daniels, Michelle, Wirtz, Carol J., Stout, John J., Quigley, James J.
Format:	Artikel
Sprache:	eng
Schlagworte:	Adverse drug reactions AIDS AIDS/HIV Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences Clinical Infectious Disease Articles Clinical trials Didanosine - therapeutic use Dosage Drug Tolerance Drugs, Investigational - therapeutic use Employee assistance programs Health Services Accessibility HIV infections HIV Infections - drug therapy human immunodeficiency virus Humans Institutional review boards Investigational drugs Medical sciences Medication Systems Medications Models, Biological Pharmacology. Drug treatments Physicians United States United States Food and Drug Administration
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Beschreibung
Zusammenfassung:	The purpose of the didanosine Expanded Access Program was to provide a needed antiretro-viral agent to individuals who were unable to tolerate other therapy for human immunodeficiency virus infection or in whom such therapy was failing. The logistics of establishing this program are described, and the results of on-site auditing that confirmed the validity of the data obtained through this program are presented.
ISSN:	1058-4838 1537-6591
DOI:	10.1093/clinids/19.6.1071