Bioequivalence and Bioavailability Forum

Bioequivalence study [Design Issues]

posted by Helmut  – Vienna, Austria, 2016-05-03 19:44 (3245 d 01:29 ago) – Posting: # 16274
Views: 8,910

Dear Detlew,

❝ To be not bounded by an document called "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" in his assessment?

Nope. The guess of nobody above was correct. Let me highlight the relevant part:
"GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE"
We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result).
The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?”

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

• Reg-Bio Availability or Bio Equivalence study pravin17 2016-05-03 08:07 [Design Issues] 
  • 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 studyHelmut 2016-05-03 17:44
        • Investigation of ... d_labes 2016-05-04 08:43