Bioequivalence and Bioavailability Forum

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

posted by nobody – 2016-10-20 14:27 (3176 d 02:22 ago) – Posting: # 16742
Views: 9,180

❝ ❝ How would you define "right"?

Right in the sense of: I'm able to show BE (a priori or a posteriori  )


I guess there are two options:

1. The originators' batches are not bioequivalent (or even bioinequivalent), but therapeutically equivalent.

Why should the generic show bioequivalence to more than one batch?

2. The originators' batches are not bioequivalent (or even bioinequivalent) AND are NOT therapeutically equivalent.

Why should such a product be allowed to be marketed?

Complete thread:

• Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 10:00 [Design Issues] 
  • 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