Slowly going OT: BE study simulations [Regulatives / Guidelines]

posted by Ohlbe – France, 2016-02-13 14:10 (3373 d 09:10 ago) – Posting: # 15988
Views: 21,129

(edited on 2016-02-14 00:56)

Dear Helmut,

❝ Agree. See this stupid example (slides 46–49) from the early days of LC/MS-MS (no stable isotope IS and hit by the matrix effect). Slide 49 compares results of the first 12 (of 24) subjects obtained by the lousy LC/MS-MS method with stable isotope IS GC/MS. Does it matter? No.


Well, cough... In your example there is not much difference for AUC, agreed. But Cmax ? A difference of 4 points in the point estimate, closer to 1 with the lousy method, with 90 % CI of 78.6 - 99.8 % with the lousy method against 71.1 - 96.4 % with the good method... In this specific example I would say that yes, it could have mattered, and made a difference between a failing study and a passing study !

Regards
Ohlbe

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