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Revised EMA guideline on first-in-human and early phase studies [Regulatives / Guidelines]

posted by Ohlbe - France, 2017-07-25 18:52  - Posting: # 17614
Views: 406

Dear all,

I know this is a bit far from bioequivalence trials, but we had some discussions on FIM here after the Bial trial accident.

The EMA has published today its revised guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

According to the associated press release, the overview of comments will be published in September.

Regards
Ohlbe

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