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 (3701 d 10:57 ago) – Posting: # 16298
Views: 4,344

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
- 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

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