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Editorial
. 2024 Jul;90(7):1538-1540.
doi: 10.1111/bcp.16141. Epub 2024 Jun 16.

The safety of early phase clinical trials: Bridging the gap between governance and practice

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Free article
Editorial

The safety of early phase clinical trials: Bridging the gap between governance and practice

Ulrike Lorch et al. Br J Clin Pharmacol. 2024 Jul.
Free article
No abstract available

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References

REFERENCES

    1. Declaration of Helsinki. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-pr...
    1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Accessed 30 April 2024, https://www.ich.org/page/ich-guidelines
    1. European Medicines Agency Scientific Guidelines. Accessed 30 April 2024, https://www.ema.europa.eu/en/human-regulatory-overview/research-and-deve...
    1. European Medicines Agency. Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products. Accessed 30 April 2024, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-st...
    1. Medicines Health and Regulatory Agency Clinical Trials Guidelines. https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-auth...

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