Bioequivalence and Bioavailability Forum

WHO frequent deficiencies in protocols and reports [BE/BA News]

posted by ElMaestro  – Denmark, 2020-12-04 15:10 (2019 d 14:24 ago) – Posting: # 22113
Views: 10,388

Thanks Ohlbe,

does anyone know what this sentence means: "The calculation of the 90% confidence interval (CI) of the mean test/comparator ratio for the primary PK parameters should not be confused with the two one-sided t-tests employed to reject the null hypothesis of non-equivalence. The end result is the same, but these are not the same calculations."

Complete thread:

• WHO frequent deficiencies in protocols and reports Ohlbe 2020-12-04 12:04 [BE/BA News] 
  • WHO frequent deficiencies in protocols and reportsElMaestro 2020-12-04 14:10
    • CI inclusion ≠ TOST Helmut 2020-12-04 20:30
      • CI inclusion ≠ TOST d_labes 2020-12-05 16:19
        • CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
          • CI inclusion ≠ TOST d_labes 2020-12-07 11:39
        • CI inclusion ≠ TOST Helmut 2020-12-06 22:09
          • CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
            • WHO lamenting about terminology? Helmut 2020-12-07 13:02
              • WHO lamenting about terminology? ElMaestro 2020-12-07 14:54
              • WHO lamenting about terminology? d_labes 2020-12-07 15:35
  • WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 19:00
    • "obtain balanced groups" vs randomisation ElMaestro 2020-12-23 08:12