Bioequivalence and Bioavailability Forum

Shorter sampling interval in pilot - Good idea? [Design Issues]

posted by nobody – 2018-02-28 09:36 (2409 d 11:57 ago) – Posting: # 18477
Views: 3,300

❝ There was a weirdo who wrote a paper about pilot and repeat trials as development tools in BE. The author's only regret is that he presented the data the way he did. It would have appealed more to the broad audience if he had graphed the chance of taking the wrong decision in the various scenarios when the decision was to be based on the location of the apparent T/R.

Yep, next time you send me your draft and we discuss the data presentation.

GMR of AUC is of some interest to judge which formulation to take to the pivotal (one from pilot(s) or maybe something completely different?). Not so much for sample size. Would take 0.9 plus CVintra estimated for Test from pilot(s) and see where one ends (1 gazillion of HVs?)...

Complete thread:

• Shorter sampling interval in pilot - Good idea? nobody 2018-02-27 19:02 [Design Issues] 
  • Shorter sampling interval in pilot - Good idea? ElMaestro 2018-02-27 21:42
    • Shorter sampling interval in pilot - Good idea? nobody 2018-02-27 22:47
      • Shorter sampling interval in pilot - Good idea? ElMaestro 2018-02-27 22:58
        • Shorter sampling interval in pilot - Good idea?nobody 2018-02-28 08:36