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Editorial
. 2018 Jul;84(7):1399-1400.
doi: 10.1111/bcp.13599. Epub 2018 May 30.

Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP

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Editorial

Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP

Adam Cohen et al. Br J Clin Pharmacol. 2018 Jul.
No abstract available

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References

    1. Eddleston M, Cohen AF, Webb DJ. Implications of the BIA‐102474‐101 study for review of first‐into‐human clinical trials. Br J Clin Pharmacol 2016; 81: 582–586. - PMC - PubMed
    1. Kerbrat A, Ferré J‐C, Fillatre P, Ronzière T, Vannier S, Carsin‐Nicol B, et al Acute neurologic disorder from an inhibitor of fatty acid amide hydrolase. N Engl J Med 2016; 375: 1717–1725. - PubMed
    1. van Gerven J, Bonelli M. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products. Br J Clin Pharmacol 2018; 84: 1401–1409. - PMC - PubMed

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