Bioequivalence and Bioavailability Forum • How to calculate this assumption...if AUCt is at least 80% of AUC∞...

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

posted by ElMaestro – Denmark, 2017-03-30 17:08 (3372 d 03:13 ago) – Posting: # 17215
Views: 5,127
(edited on 2017-03-30 18:25)

Hola javier,

❝ One more question,assuming that we will do the pilot trial, (in our case would be a healthy volunteer study because there is no safety concern about the drug)and the end of the day the question is the same right, How can we sure that que are taking enough sampling to cover the 80% of AUC-inf?

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.

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Pass or fail!
ElMaestro

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