Bioequivalence and Bioavailability Forum • Can of worms

Can of worms [Design Issues]

posted by Helmut – Vienna, Austria, 2017-02-16 15:50 (2623 d 18:10 ago) – Posting: # 17075
Views: 6,748

Hi ElMaestro & Mikkabel,

❝ I am not saying it will never work, but I am saying it does not generally work. A famous publication not too long ago was one by Elise B Getz and colleagues from Oriel who went that way with DPI's containing Fp and Sx. This isn't for the fainthearted.

❝

❝ Be very, very careful now.

Exactly. You should not try to open the can of worms.*

Burmeister Getz E, Carroll KJ, Jones B, Benet LZ. Batch-to-Batch Pharmacokinetic Variability Confounds Current Bioequivalence Regulations: A Dry Powder Inhaler Randomized Clinical Trial. Clin Pharm Ther. 2016;100(3):223–231. doi:10.1002/cpt.373. free resource

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Complete thread:

Replicate or not? Mikkabel 2017-02-16 12:18 [Design Issues]
- Replicate or not? DavidManteigas 2017-02-16 13:04
  - Replicate or not? Mikkabel 2017-02-16 13:50
- Replicate or not? ElMaestro 2017-02-16 13:48
  - Replicate or not? nobody 2017-02-16 14:10
  - Replicate or not? Mikkabel 2017-02-16 14:12
    - Replicate or not? ElMaestro 2017-02-16 14:24
      - Can of wormsHelmut 2017-02-16 14:50
      - Replicate or not? Mikkabel 2017-02-16 15:45
        
        Replicate or not? nobody 2017-02-16 18:05