Bioequivalence and Bioavailability Forum • Generic FDC: EMA-approach

Generic FDC: EMA-approach [Design Issues]

posted by Beholder – Russia, 2018-09-04 15:27 (2491 d 11:25 ago) – Posting: # 19236
Views: 4,512

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: :lookaround: )

Scientific advice in Russia now can be described only as :lookaround:

:lookaround:

. Joke.

THX one more time for valuable info.

—
Best regards
Beholder

Complete thread:

Generic FDC drug vs two monoproduct drug or vs "originator" FDC drug? Beholder 2018-09-04 11:12 [Design Issues]
- 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

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