Bioequivalence and Bioavailability Forum • FDCPs: generally BE (higher BA under certain conditions)

FDCPs: generally BE (higher BA under certain conditions) [Regulatives / Guidelines]

posted by nobody – 2016-05-12 15:41 (3342 d 18:20 ago) – Posting: # 16298
Views: 3,721

Hi!

...just to add: There is a MAY-2015 draft of the EMA guideline on this topic, not further addressing the criteria for DDI studies, iirc...

—
Kindest regards, nobody

Complete thread:

Pharmacokinetic interaction study Mahesh M 2016-05-12 07:07 [Regulatives / Guidelines]
- FDCPs: generally BE (higher BA under certain conditions) Helmut 2016-05-12 13:15
  - FDCPs: generally BE (higher BA under certain conditions)nobody 2016-05-12 13:41
    - FDCPs: generally BE (higher BA under certain conditions) Mauricio Sampaio 2016-05-19 05:47
- Pharmacokinetic interaction study Dr_Dan 2016-05-19 10:05
  - Pharmacokinetic interaction study nobody 2016-05-20 09:40

Admin contact
23,427 posts in 4,929 threads, 1,681 registered users;
50 visitors (0 registered, 50 guests [including 17 identified bots]).
Forum time: 10:02 CEST (Europe/Vienna)

No matter what side of the argument you are on,
you always find people on your side
that you wish were on the other. Thomas Berger

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz