Bioequivalence and Bioavailability Forum

GRLS data [Power / Sample Size]

posted by Ohlbe – France, 2019-03-14 01:08 (1864 d 10:28 ago) – Posting: # 20033
Views: 3,540

Dear Mittyri,

❝ By the way GRLS says that at least 2 companies performed BEQ studies. The sample size was (unfortunately we don't know exactly what 'the number of patients' means - sample size? number of subjects intended to be screened?) not more than 22 and 40. I would say this is not HVD.

Well, it depends... Does it say whether this sample size was sufficient to conclude ? Maybe they tried their luck (as considered by Elena) and failed with a 90 % CI of 34 - 192 %

Complete thread:

• Chloropyramine BE study Elena777 2019-03-13 17:17 
  • Pilot study Helmut 2019-03-13 18:08
    • Pilot study Elena777 2019-03-13 18:55
  • GRLS data mittyri 2019-03-13 23:06
    • GRLS dataOhlbe 2019-03-14 00:08
      • lucky sponsors mittyri 2019-03-14 11:28