Bioequivalence and Bioavailability Forum • Chewable tablets (EMA)

Chewable tablets (EMA) [Design Issues]

posted by Helmut – Vienna, Austria, 2012-01-11 15:19 (5285 d 06:45 ago) – Posting: # 7900
Views: 9,246

Dear Jagdish!

❝ Dear HS,

^^ not interested in opinions of other members?

❝ can you tell me how montelukast should be administered during BE study for european submission with water after chewing or without water after chewing

See the GL, Appendix II, Orodispersible tablets and the last paragraph:

Other oral formulations such as […] chewable tablets may be handled in a similar way as for ODTs. Bioequivalence studies should be conducted according to the recommended use of the product.

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Helmut Schütz

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Complete thread:

Montelukast study Phaneendra.K 2010-12-31 15:06
- Montelukast study Helmut 2010-12-31 15:35
  - tablets jagdish 2012-01-11 13:43
    - Chewable tablets (EMA)Helmut 2012-01-11 14:19
      - Chewable tablets (EMA) jagdish 2012-01-12 11:12
        
        Chewable tablets (EMA) Helmut 2012-01-13 17:26
- Montelukast study manan 2011-01-01 06:16
  - Montelukast study Phaneendra.K 2011-01-02 09:32
    - FDA’s guidances, lightsensitive drugs Helmut 2011-01-02 15:13
      - FDA’s guidances, lightsensitive drugs manan 2011-01-03 05:52
        
        Lightsensitive drugs Helmut 2011-01-03 15:22