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 nobody – 2016-10-20 16:27 (3534 d 04:29 ago) – Posting: # 16746
Views: 10,221

❝ RLD batches not bioequivalent AND are NOT therapeutically equivalent => serious risk to public health. You kill the originator after establishing your product on the market :-D

...hmmm, would such a "Generic" get marketing authorization? Would you have to show "better" batch-to-batch performance for your generic formulation? I'm inclined to say: The originator has to get his quality issues under control (recall lousy batches from the market?) and no generic should be allowed AT ALL in the meantime.

This whole story reminds of the good old days when BE was invented to keep companies from marketing lousy products with erratic biopharmaceutical properties. Maybe it is time to get a little tougher on this inhalation-stuff?

—
Kindest regards, nobody

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