Bioequivalence and Bioavailability Forum

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

posted by javier – Spain, 2017-03-30 16:12 (2577 d 11:14 ago) – Posting: # 17214
Views: 3,526

Hi ElMaestro!

❝ This is not what you want to do. This what your boss wants you to do.

I couldnt agree more with you

❝ I recommend that you do a pilot trial and forget all about the info on the SPC. You are facing a source of error that is potentially much much higher than what you are used to from synthetics.

❝ I think a pilot trial in a dedicated phase I facility is also the ethically correct thing to do.

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?

Forgive me for insisting but at heart i want to know how to do it just only for improving my kownlegde in pharmacology

Thanks in advance

Complete thread:

• How to calculate this assumption...if AUCt is at least 80% of AUC∞... javier 2017-03-28 23:21 [Design Issues] 
  • 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