EU + US [Dissolution / BCS / IVIVC]
Dear Jayesh,
No "Orange book" here. See Helmut's message in this thread and my response.
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.
No reason why they should not.
You have to comply with both the EU and US BE guidelines and all regulations. See the guidance page.
Regards
Ohlbe
❝ 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
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
- F1 and F2 values and dissolution profile drcampos 2009-03-06 14:31
- 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