Bioequivalence and Bioavailability Forum • Generic FDC: EMA-approach

Generic FDC: EMA-approach [Design Issues]

posted by Beholder – Russia, 2018-09-04 17:23 (2854 d 04:45 ago) – Posting: # 19238
Views: 5,358

Dear Helmut,

❝ I forgot that at last year’s BioBridges Marina Feřtek of the Czech State institute for drug control (SÚKL) gave a presentation about FDCs.

Yes, saw that the conference took place and wanted to go throght the presentations. Good occasion now. Thank you.

—
Best regards
Beholder

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-approach Beholder 2018-09-04 13:27
    - Generic FDC: EMA-approach Helmut 2018-09-04 13:38
      - Generic FDC: EMA-approachBeholder 2018-09-04 15:23