Bioequivalence and Bioavailability Forum • Fast Dissolve Tablet Versus Immediate Release Tablet

Fast Dissolve Tablet Versus Immediate Release Tablet [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2013-06-20 11:53 (4751 d 18:37 ago) – Posting: # 10836
Views: 4,864

Dear Kranti
The information, that your test product is a nutraceutical product, which can be marketed without any approval from regulatory makes a huge difference. As John pointed out you just need to justify that the intended higher bioavailability with the ODT in the same strength as the RLD (peak plasma levels and total bioavailability) is safe and tolerable. Then it should be possible to demonstrate superiority (higher bio availability) as marketing tool for your ODT.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

Fast Dissolve Tablet Versus Immediate Release Tablet kranti 2013-06-19 09:39
- Fast Dissolve Tablet Versus Immediate Release Tablet Dr_Dan 2013-06-19 12:49
  - Fast Dissolve Tablet Versus Immediate Release Tablet kranti 2013-06-19 13:56
    - Fast Dissolve Tablet Versus Immediate Release Tablet jag009 2013-06-19 19:54
    - Fast Dissolve Tablet Versus Immediate Release TabletDr_Dan 2013-06-20 09:53
      - Fast Dissolve Tablet Versus Immediate Release Tablet kranti 2013-06-24 10:45
        
        Dispersible tablets and Oral suspension kumarnaidu 2013-11-12 10:58
        
        Dispersible tablets and Oral suspension Dr_Dan 2013-11-13 11:46
        
        Dispersible tablets and Oral suspension kumarnaidu 2013-11-14 06:29