Bioequivalence and Bioavailability Forum • EU + US

EU + US [Dissolution / BCS / IVIVC]

posted by Ohlbe – France, 2010-04-17 22:19 (5503 d 13:59 ago) – Posting: # 5161
Views: 25,835

Dear Jayesh,

❝ 1. How to select Reference drug for EU market ? Is ther any system/website just like orange book for USFDA ?

No "Orange book" here. See Helmut's message in this thread and my response.

❝ 2. Can we plan a single 3WC study using RLD from USA and EU ?

Yes, as long as you manage to comply with all requirements from both sides. Until now I have seen trials with reference products from EU and Switzerland and EU + Australia, but never with EU + US.

❝ 3. If our product fail to bioequivalent to USFDA, but it is bioequivalent to EU then does EU accept our dossier ?

No reason why they should not.

❝ 4. Is there any regulatory issue for conducting this study ?

You have to comply with both the EU and US BE guidelines and all regulations. See the guidance page.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

F1 and F2 values and dissolution profile govardhanpillari 2009-03-04 12:30 [Dissolution / BCS / IVIVC]
- F1 and F2 values and dissolution profile drcampos 2009-03-04 13:51
- F1 and F2 values and dissolution profile Aceto81 2009-03-05 12:30
  - F1 and F2 values and dissolution profile Helmut 2009-03-05 14:01
  - F1 and F2 values and dissolution profile govardhanpillari 2009-03-06 06:04
    - F1 and F2 values and dissolution profile drcampos 2009-03-06 14:31
      - F1 and F2 values and dissolution profile govardhanpillari 2009-03-07 05:47
- US RLD / European reference Helmut 2009-03-05 14:15
  - European reference Ohlbe 2009-03-05 19:09
- F1 and F2 values and dissolution profile jayeshd 2010-04-17 08:58
  - EU + USOhlbe 2010-04-17 20:19
  - F1 and F2 values and dissolution profile Dr_Dan 2010-04-19 14:51