S11-4 Ethical, regulatory issues to learn from the TGN1412 case
نویسندگان
چکیده
منابع مشابه
TGN1412: From Discovery to Disaster
After a drug is confirmed as safe and efficacious in preclinical studies, it is tested in healthy human volunteers for first in man trials. In 2006, a phase I clinical study was conducted for a CD28 superagonist antibody TGN1412 in six human volunteers. After very first infusion of a dose 500 times smaller than that found safe in animal studies, all six human volunteers faced life-threatening c...
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ژورنال
عنوان ژورنال: Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
سال: 2008
ISSN: 0388-1601,1882-8272
DOI: 10.3999/jscpt.39.113s