bioequivalence criteria for NTID [Regulatives / Guidelines]
As per Draft Guidance on Warfarin Sodium bioequivalence criteria for NTID as
- Every study should pass the scaled average bioequivalence limits and
- Also regular unscaled bioequivalence limits of 80.00-125.00%.
- the upper limit of the 90% equal-tails confidence interval for σwT/σwR is less than or equal to 2.5
- The 95% upper confidence bound for (YT – YR)2 – θs2wR must be ≤ 0 and the point estimate of the Test/Reference geometric mean ratio must fall within 80.00 – 125.00%. (scaled average bioequivalence limits)
- 90% confidence interval should lies within 80–125% (unscaled bioequivalence limits)
Thanks in advanced.
- bioequivalence criteria for NTID - Biostats, 2018-03-29 12:39 [Regulatives / Guidelines]