Bioequivalence and Bioavailability Forum • Different strenghts

Different strenghts [Design Issues]

posted by cher0424 – China, 2014-12-22 03:30 (4208 d 10:04 ago) – Posting: # 14131
Views: 5,842

Hi Helmut

❝ One of my cases: Only IR on the market. One product 5/10/20 mg, another one 10/20/40 mg. Maximum approved daily dose 60 mg.

❝ • 20 mg new MR vs. 2 × 10 mg IR, hybrid pathway (two clinical studies; individualized doses up to 60 mg). ⇒ Approval of 20 mg.

Can you specify what are these two clinical studies? One BE, and one dose up study?

Complete thread:

Different strenghts prashantmohite 2014-12-20 04:57
- Different strenghts ElMaestro 2014-12-20 13:19
  - Different strenghts Helmut 2014-12-20 14:24
    - Different strenghtscher0424 2014-12-22 02:30
      - Different strenghts Helmut 2014-12-22 02:58
        
        Different strenghts mittyri 2014-12-22 20:30

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