Доклинические исследования: основные принципы

Дополнительные источники
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strategies to identify and mitigate risks for first-in
human trials with investigational medicinal products.
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requirements for first-in-man clinical trials for
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European Medicines Agency (2009). ICH guideline M3(R2)
on non-clinical safety studies for the conduct of human
clinical trials and marketing authorisation for
pharmaceuticals. London: European Medicines Agency.
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European Medicines Agency (2011). Committee for
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Справочная литература
Image reproduced from ICH (2015). M4: The Common
1.
Technical Document. Retrieved 11 July, 2021, from
https://www.ich.org/page/ctd
European Medicines Agency (2009). ICH guideline M3(R2)
2.
on non-clinical safety studies for the conduct of human
clinical trials and marketing authorisation for
pharmaceuticals.  London: European Medicines Agency.
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