Expanded Access Programs: Ethical and Practical Considerations for Biopharmaceutical Sponsors
نویسندگان
چکیده
منابع مشابه
Expanded Access Programs
Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval access to an investigational drug can be provided to a group of patients. Altho...
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ژورنال
عنوان ژورنال: Therapeutic Innovation & Regulatory Science
سال: 2015
ISSN: 2168-4790,2168-4804
DOI: 10.1177/2168479015578154