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bioequivalence criteria for NTID [Regulatives / Guidelines]

posted by Biostats - India, 2018-03-29 12:39  - Posting: # 18613
Views: 2,662

Dear All,

As per Draft Guidance on Warfarin Sodium bioequivalence criteria for NTID as
  1. Every study should pass the scaled average bioequivalence limits and
  2. Also regular unscaled bioequivalence limits of 80.00-125.00%.
  3. the upper limit of the 90% equal-tails confidence interval for σwT/σwR is less than or equal to 2.5
My understanding for 1 and 2 criteria as below,
  1. The 95% upper confidence bound for (YTYR)2θs2wR 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)
  2. 90% confidence interval should lies within 80–125% (unscaled bioequivalence limits)
Is this correct? Please guide me to understand the bioequivalence criteria of NTI drugs.

Thanks in advanced.

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