Bioequivalence and Bioavailability Forum

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

posted by Dr_Dan  – Germany, 2016-10-20 14:49 (3530 d 20:42 ago) – Posting: # 16743
Views: 10,213

Correct, I totally agree
RLD batches not bioequivalent, but therapeutically equivalent => no PK/PD relationship and consequently batch-to-batch variability does not matter.
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

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