High-risk molecules or insufficient scientific data?
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.
Mignot
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SGS Life Science Services, Saint Benoit, France. Alain.Mignot@sgs.com
D016907:Adverse Drug Reaction Reporting Systems; D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D035843:Biomedical Research / Q000941:ethics* / Q000592:standards; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D004305:Dose-Response Relationship, Drug; D004353:Drug Evaluation, Preclinical / Q000941:ethics* / Q000592:standards; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D018570:Risk Assessment; D013329:Structure-Activity Relationship; D014481:United States
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C509303:TGN-1412