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. 2006 Oct;62(4):502-3.

doi: 10.1111/j.1365-2125.2006.02740.x. Epub 2006 Jul 3.

After the London tragedy, is it still possible to consider Phase I is safe?

Michel Sibille, Yves Donazzolo, Franck Lecoz, Emmanuel Krupka

PMID: 16817849
PMCID: PMC1885163
DOI: 10.1111/j.1365-2125.2006.02740.x

After the London tragedy, is it still possible to consider Phase I is safe?

Michel Sibille et al. Br J Clin Pharmacol. 2006 Oct.

. 2006 Oct;62(4):502-3.

doi: 10.1111/j.1365-2125.2006.02740.x. Epub 2006 Jul 3.

Authors

Michel Sibille, Yves Donazzolo, Franck Lecoz, Emmanuel Krupka

PMID: 16817849
PMCID: PMC1885163
DOI: 10.1111/j.1365-2125.2006.02740.x

No abstract available

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References

1. Mayor S. Inquiry into adverse events in trial blames drug, not study design. BMJ. 2006;332:870. - PMC - PubMed
1. McCarthy M. John’s Hopkins case: healthy volunteer dies in US physiology study. Lancet. 2001;357:2114. - PubMed
1. Cottington EM, LaMantia C, Stabler SP, Allen RH, Tangerman A, Wagner C, Zeisel SH, Mudd SH. Adverse event associated with methionine loading test: a case report. Arterioscler Thromb Vasc Biol. 2002;22:1046–50. - PubMed
1. Healthy 19 year volunteer suicide. Indianapolis Star 10 February 2004.
1. Sibille M, Deigat N, Janin A, Kirkesseli S, Vital Durand D. Adverse events in phase I studies – a report in 1015 healthy volunteers. Eur J Clin Pharmacol. 1998;54:13–20. - PubMed

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