Bioequivalence and Bioavailability Forum

How to calculate this assumption...if AUCt is at least 80% of AUC∞... [Design Issues]

posted by javier – Spain, 2017-03-31 00:44 (3376 d 07:19 ago) – Posting: # 17216
Views: 5,114

❝ The purpose of your pilot is dual: To get an idea of variability so that your can dimension your pivotal trial appropriately, and to establish the time by which AUCt>0.8*AUCinf in the majority of (expected future) trial patients/volunteers.

Thanks again for the answer (y por el tiempo que me has dedicado en contestar a la pregunta, que no es poca cosa)

Best regards

Javier

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

• How to calculate this assumption...if AUCt is at least 80% of AUC∞... javier 2017-03-28 23:21 
  • How to calculate this assumption...if AUCt is at least 80% of AUC∞... javier 2017-03-30 13:36
  • How to calculate this assumption...if AUCt is at least 80% of AUC∞... ElMaestro 2017-03-30 13:54
    • How to calculate this assumption...if AUCt is at least 80% of AUC∞... javier 2017-03-30 14:12
      • How to calculate this assumption...if AUCt is at least 80% of AUC∞... ElMaestro 2017-03-30 15:08
        • How to calculate this assumption...if AUCt is at least 80% of AUC∞...javier 2017-03-30 22:44