F1 and F2 values and dissolution profile [Dissolution / BCS / IVIVC]
Hi Govardhan,
We are also planning to do a single BE study for EU and USA market. Now we dont know how to go about bio studies.
I would like to know about;
thanks
Jayesh
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
We are also planning to do a single BE study for EU and USA market. Now we dont know how to go about bio studies.
I would like to know about;
- How to select Reference drug for EU market ? Is ther any system/website just like orange book for USFDA ?
- Can we plan a single 3WC study using RLD from USA and EU ?
- If our product fail to bioequivalent to USFDA, but it is bioequivalent to EU then does EU accept our dossier ?
- Is there any regularoty issue for conducting this study ?
thanks
Jayesh
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [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 profilejayeshd 2010-04-17 08:58
- EU + US Ohlbe 2010-04-17 20:19
- F1 and F2 values and dissolution profile Dr_Dan 2010-04-19 14:51