Bioequivalence and Bioavailability Forum • BE Studies for OTC-drug

BE Studies for OTC-drug [Regulatives / Guidelines]

posted by kumar – 2009-04-25 16:58 (6275 d 12:36 ago) – Posting: # 3613
Views: 6,046

Dear EM,

Thank you for the mail. This product is already authorised in EU & USA as an innovator. The drug is not locally acting. We have seen the SPC and is not of much help. As a generic product, we need to demonstrate its BE with the innovator. We do not have much bibliographic reference to ask for a waiver? We do not know in what way we can conduct clinical trials and BE Studies.
Need help.

Regards
Kumar

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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! Helmut

Complete thread:

BE Studies for OTC-drug kumar 2009-04-25 13:14
- BE Studies for OTC-drug ElMaestro 2009-04-25 14:32
  - BE Studies for OTC-drugkumar 2009-04-25 14:58
    - No full quotes, please! Helmut 2009-04-25 15:34
      - No full quotes, please! kumar 2009-04-27 07:52
        
        Off topic: Full quote Helmut 2009-04-27 13:46
        
        Off topic: Full quote kumar 2009-04-27 15:18
        
        Off topic: Full quote Helmut 2009-04-27 16:00
      - BE Studies for OTC-drug kumar 2009-04-27 07:58
        
        Off topic: Subject line Helmut 2009-04-27 11:55
    - BE Studies for OTC-drug ElMaestro 2009-04-25 22:43
      - BE for new indication under POM category of an OTC-drug kumar 2009-04-27 08:14
        
        BE for new indication under POM category of an OTC-drug ElMaestro 2009-04-27 18:44
        
        No CSI Miami Helmut 2009-04-27 20:34
        
        No CSI Miami ElMaestro 2009-04-28 19:35
        
        Belgian seamanship Helmut 2009-04-28 19:43
        
        BE for new indication under POM category of an OTC-drug kumar 2009-04-28 08:28
        
        Clinical trials for new indication Ohlbe 2009-04-28 11:34
        
        Clinical trials for new indication & Orphan status kumar 2009-04-29 12:42
        
        Clinical trials ! Ohlbe 2009-04-29 13:53