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. 2018 Jul;84(7):1401-1409.
doi: 10.1111/bcp.13550. Epub 2018 May 30.

Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Joop van Gerven  1 , Milton Bonelli  2
Affiliations

Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Joop van Gerven et al. Br J Clin Pharmacol. 2018 Jul.
No abstract available

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References

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    1. Expert group on phase one clinical trials (chairman: Professor Gordon W. Duff) expert group on phase one clinical trials: final report 2006 TSO (the stationary office).
    1. Horvath CJ, Milton MN. The TeGenero incident and the Duff Report conclusions: a series of unfortunate events or an avoidable event? Toxicol Pathol 2009; 37: 372–383. - PubMed
    1. Kenter MJ, Cohen AF. Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet 2006; 368: 1387–1391. - PubMed

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