Bioequivalence and Bioavailability Forum

Generic FDC: EMA-approach [Design Issues]

posted by Beholder  – Russia, 2018-09-04 15:27 (2496 d 09:30 ago) – Posting: # 19236
Views: 4,515

Hi Helmut,

❝ I don’t know the state of affairs in Russia and/or the EEU but

Looks like there is no GL for FDC in Russia but there is in EEC (under development).

❝ scientific advice (Russia: )

Scientific advice in Russia now can be described only as . Joke.

THX one more time for valuable info.

Complete thread:

• Generic FDC drug vs two monoproduct drug or vs "originator" FDC drug? Beholder 2018-09-04 11:12 
  • Generic FDC: EMA-approach Helmut 2018-09-04 13:04
    • Generic FDC: EMA-approachBeholder 2018-09-04 13:27
      • Generic FDC: EMA-approach Helmut 2018-09-04 13:38
        • Generic FDC: EMA-approach Beholder 2018-09-04 15:23