Bioequivalence and Bioavailability Forum • Pharmacokinetic interaction study

Pharmacokinetic interaction study [Regulatives / Guidelines]

posted by nobody – 2016-05-20 11:40 (3333 d 00:48 ago) – Posting: # 16343
Views: 3,594

I would support this opinion (at least for EU), as the EMA DDI Guideline as of 2012 does not require formal BE testing. Why should this be more rigid for new FDCs?

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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 studynobody 2016-05-20 09:40