The FDA’s fourth BE approach! [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2015-09-22 13:43 (3430 d 16:05 ago) – Posting: # 15439
Views: 18,116

Hi nobody,

❝ Any info on what has changed from 2012 draft to 2015 version?


Jun 2012Sep 2015
Apart from the additional safety parameters for inclusion and the BE requirement of total dabigatran the statistics are interesting – going from RSABE (widening of implied limits) to sumfink similar to Warfarin. No narrowing of BE limits but still the comparison of variances.*

This gives yet a fourth BE approach stated by the FDA:
  1. Generally average BE; acceptance range 80.00–125.00%. Designs: Two-period crossover, higher-order crossovers, parallel, full (4-period) or partial replicate (3-period).
  2. RSABE for HVDs/HVDPs if \(\small{s_\text{wR}\geq 0.294}\). GMR-restriction 0.8000–1.2500. Designs full (4-period) or partial replicate (3-period).
  3. RSABE for NTIDs. Narrowing BE-limits based on \(\small{s_\text{wR}}\). Must pass conventional ABE as well. Upper CL of \(\small{s_\text{wT}/s_\text{wR}\leq 2.5}\). Design full (4-period) replicate.
  4. As above but conventional BE limits (no downscaling).


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