Bioequivalence Limit, Power and interpretation [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-09-22 13:27 (305 d 13:20 ago) – Posting: # 21930
Views: 1,423

Dear All,

I just want basic information about Bioequivalence limit with respect to power and number of subjects.
  1. What to conclude if we got the result where study is failed in lower side i.e. below 80%...
  2. What to conclude if we got the result where study is failed in upper side i.e. above 125%...
  3. What to conclude where study's post hoc power is less then 80 or 85%?

What are the main factors associated with apart from human or instrument error?

Thanks.

Dr. Pharma88

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