Bioequivalence and Bioavailability Forum • FDA’s guidances, lightsensitive drugs

FDA’s guidances, lightsensitive drugs [Design Issues]

posted by Helmut – Vienna, Austria, 2011-01-02 16:13 (5643 d 00:41 ago) – Posting: # 6384
Views: 10,313

Dear Phani and Manan!

❝ It is Monteleukast Sodium film coated tablets. But are the criteria diffetent for different formulations. How.

See FDA’s guidances, Section ‘Bioavailability / Bioequivalence’. There you will find a link to ‘Individual Product BE Recommendations by API’ > M > Montelukast Sodium (Granule, Tablet, Chewable Tablet). I leave it to you to check what the differences are.

❝ Also, what is the reason for the usage of monochromatic light while dosing.

Another urban myth, IMHO. I would really like to see hard data from people advocating such an error-prone procedure.
@Manan: Can you come up with a reference showing a difference, or were you just copypasting?
Concerning dosing of light sensitive drugs see this thread. A similar thread covering also bioanalytics here.

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Complete thread:

Montelukast study Phaneendra.K 2010-12-31 15:06 [Design Issues]
- 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 drugsHelmut 2011-01-02 15:13
      - FDA’s guidances, lightsensitive drugs manan 2011-01-03 05:52
        
        Lightsensitive drugs Helmut 2011-01-03 15:22