Bioequivalence and Bioavailability Forum • bioequivalence criteria for NTID

bioequivalence criteria for NTID [Regulatives / Guidelines]

posted by Biostats – India, 2018-03-29 14:39 (2216 d 19:57 ago) – Posting: # 18613
Views: 6,644

Dear All,

As per Draft Guidance on Warfarin Sodium bioequivalence criteria for NTID as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 σ_wT/σ_wR is less than or equal to 2.5

My understanding for 1 and 2 criteria as below,

The 95% upper confidence bound for (Y_T – Y_R)² – θs²_wR 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)

Is this correct? Please guide me to understand the bioequivalence criteria of NTI drugs.

Thanks in advanced.

Complete thread:

bioequivalence criteria for NTIDBiostats 2018-03-29 12:39
- bioequivalence criteria for NTID Helmut 2018-03-29 14:27
  - bioequivalence criteria for NTID Biostats 2018-03-30 06:25
    - GMR not relevant in ABE Helmut 2018-03-30 11:19
      - Presentation of data in report and SAS output arl_stat 2020-10-15 16:12
- bioequivalence criteria for NTID jag009 2018-03-29 17:20

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