Bioequivalence and Bioavailability Forum

Investigation of ... [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-04 10:43 (3698 d 22:25 ago) – Posting: # 16279
Views: 10,070

Dear Helmut,

❝ We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result).

Up to now my understanding of a bioavailability study was: A study with the aim to study the extent of availability in the body, without the aim to show equivalence. F.i. intra-venious application versus oral.

❝ The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?”

IMHO this is a very sophisticated and nitpicking attitude, suitable to wow NLYW .
In the same spirit you can't speak about non-inferiority or superiority studies.
But: "Jedem Tierchen sein Pläsierchen" (rough translation "To each their own"). Especially if it (the beastie) is an assessor.

Complete thread:

• Reg-Bio Availability or Bio Equivalence study pravin17 2016-05-03 08:07 
  • Bio Availability or Bio Equivalence study Ohlbe 2016-05-03 10:25
    • Bio Availability or Bio Equivalence study jag009 2016-05-09 23:09
      • Different rates = BE if intentional (FDA def.) Helmut 2016-05-10 16:08
        • Different rates = BE if intentional (FDA def.) Ohlbe 2016-05-10 22:03
  • Bio Availability or Bio Equivalence study nobody 2016-05-03 10:41
  • Bioequivalence study? Helmut 2016-05-03 11:55
    • Bioequivalence study? nobody 2016-05-03 14:07
    • Bioequivalence study d_labes 2016-05-03 15:50
      • Bioequivalence study Helmut 2016-05-03 17:44
        • Investigation of ...d_labes 2016-05-04 08:43