Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-08-24 06:55 CEST (UTC+2h)
 

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: 255

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,243 Posts in 3,687 Threads, 1,057 registered users;
24 users online (0 registered, 24 guests).

I try not to think with my gut.
If I’m serious about understanding the world,
thinking with anything besides my brain, as tempting as that might be,
is likely to get me into trouble.    Carl Sagan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed