Bioequivalence and Bioavailability Forum • clinical trials/ BE studies for locally acting drugs

clinical trials/ BE studies for locally acting drugs [Regulatives / Guidelines]

posted by Ohlbe – France, 2012-01-31 20:01 (5248 d 22:17 ago) – Posting: # 8034
Views: 6,187

Dear Dr Gunasakaran

Any reference to support your recommendation, including regarding metabolites ? Remember the query is for EU submission, not FDA.

Regards
Ohlbe

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Regards
Ohlbe

Complete thread:

clinical trials/ BE studies for locally acting drugs jagankm 2012-01-25 11:26 [Regulatives / Guidelines]
- clinical trials/ BE studies for locally acting drugs drgunasakaran1 2012-01-31 18:42
  - clinical trials/ BE studies for locally acting drugsOhlbe 2012-01-31 19:01
    - clinical trials/ BE studies for locally acting drugs jagankm 2012-02-06 12:00
      - clinical trials/ BE studies for locally acting drugs Tina 2013-09-16 18:10
  - clinical trials/ BE studies for locally acting drugs Tina 2013-09-19 09:45