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monelukast sodium [Regulatives / Guidelines]

posted by talr – Israel, 2008-11-09 17:11 (6443 d 00:16 ago) – Posting: # 2643
Views: 4,818

In case we will want to registered a 4mg or 5 mg drug product that was registered for adults - as a product for children, and we had performed a successful BE study in adults:
will we be required to perform a Bio equivalent study also in children?

thanks in advance for help,
Talr

Complete thread:

monelukast sodiumtalr 2008-11-09 16:11
- monelukast sodium JPL 2008-11-10 09:58
  - Montelukast sodium talr 2008-11-10 10:16
    - Montelukast sodium JPL 2008-11-13 15:02
      - Montelukast sodium Ohlbe 2008-11-13 15:42
        
        Montelukast sodium talr 2008-11-15 12:54

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