F1 and F2 values and dissolution profile [Dissolution / BCS / IVIVC]

posted by jayeshd – 2010-04-17 10:58 (5908 d 15:25 ago) – Posting: # 5159
Views: 28,821
(edited on 2010-04-17 20:12)

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;
  1. How to select Reference drug for EU market ? Is ther any system/website just like orange book for USFDA ?
  2. Can we plan a single 3WC study using RLD from USA and EU ?
  3. If our product fail to bioequivalent to USFDA, but it is bioequivalent to EU then does EU accept our dossier ?
  4. 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]

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