Phase I trials: A look at the TGN1412 controversy

Chin, Jane Y.
September 2006
Pharmaceutical Representative;Sep2006, Vol. 36 Issue 9, p47
The article presents information on the risks related to Phase I trials in drug development. In the Phase I trials, the maximum tolerated dose (MTD) of a therapeutic is assessed. After the MTD assessment, dose-limiting toxicity with unacceptable side effects is examined. The phase I trials are viewed as ethically controversial which are based on the risk-benefit ratio. There are a number of cases when phase I trials lead to the hospitalization of volunteers.


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