Bioequivalence and Bioavailability Forum • Type I error inflation caused by batch-to-batch variability of Reference?

Type I error inflation caused by batch-to-batch variability of Reference? [Design Issues]

posted by Dr_Dan – Germany, 2016-10-20 14:20 (3534 d 06:35 ago) – Posting: # 16741
Views: 10,304

❝ Hmm. Type I inflation due to high variability of Reference? Do they mean that you "by chance" ( :-D ) pick the "right" batch to show equivalence and get away with it?

If you "by chance" picked the "right" RLD batch to show equivalence, do you also need to show in-vivo that you picked the "right" test product batch? How would you define "right"?

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 10:00
- Type I error inflation caused by batch-to-batch variability of Reference? Dr_Dan 2016-10-20 12:06
  - Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 12:14
- Type I error inflation caused by batch-to-batch variability of Reference?Dr_Dan 2016-10-20 12:20
  - Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 12:27
    - Type I error inflation caused by batch-to-batch variability of Reference? Dr_Dan 2016-10-20 12:49
      - Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 14:27
- Type I error inflation caused by batch-to-batch variability of Reference? DavidManteigas 2016-10-21 10:44
  - Type I error inflation caused by batch-to-batch variability of Reference? Helmut 2016-10-24 17:12