Bioequivalence and Bioavailability Forum

Subject non compliance (or product failure?) [Study As­sess­ment]

posted by Loky do – Egypt, 2020-07-16 22:29 (508 d 21:01 ago) – Posting: # 21724
Views: 1,486

Many Thanks, Helmut for your reply

» ... it is considered acceptable that low-lier profiles can be excluded from statistical analysis […] if they occur with the same or lower frequency in the test product compared to the reference product.
» (my emphases)

Is this case-specific for this product, and its formula? or it could be followed for other products with the same cases?

thanks in advance

Complete thread:

• Subject non compliance Loky do 2020-07-15 12:57 [Study As­sess­ment] 
  • Subject non compliance (or product failure?) Helmut 2020-07-16 14:30
    • Subject non compliance (or product failure?)Loky do 2020-07-16 22:29
      • Bad science (statistics is taboo) Helmut 2020-07-17 01:01
        • unexpected behavior for test product Loky do 2020-07-22 11:29
          • Subject-by-Formulation interaction? Helmut 2020-07-22 12:03
            • Subject-by-Formulation interaction? Loky do 2020-07-26 11:30