Ethics
Clinical Pharmacology & Therapeutics (2008); doi:10.1038/sj.clpt.6100460
High-risk Molecules or Insufficient Scientific Data?
A Mignot1
1SGS Life Science Services, Saint Benoit, France
Correspondence: A Mignot, (Alain.Mignot@sgs.com)
Received 8 October 2007; Accepted 30 October 2007; Published online 19 December 2007.
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Abstract
When I was invited to author an ethics policy piece on the "approach to high-risk molecules" as a contribution to the theme of "Innovation in Drug Development" of this Clinical Pharmacology & Therapeutics issue, I thought there was a need to evaluate whether questioning the transition from preclinical to clinical development after the TGN 1412 serious adverse event may freeze the development of innovating tools in drug development.
