Bioequivalence and Bioavailability Forum

Bioequivalence study [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-03 17:50 (3703 d 23:40 ago) – Posting: # 16272
Views: 10,187

Hi Helmut,

❝ I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR.

❝

❝ Homework: Why does he do so?

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

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 studyd_labes 2016-05-03 15:50
      • Bioequivalence study Helmut 2016-05-03 17:44
        • Investigation of ... d_labes 2016-05-04 08:43