Which model? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2015-07-02 18:41 (3511 d 06:44 ago) – Posting: # 15022
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Hi Lucas,

❝ I do not like partial replicate designs also. I have a feeling that, taking those converging problems aside, …


To me it is not clear which statistical model HC prefers (see this post). Sounds like a mixed-effects model (FDA’s 2001 guidance, FDA’s progesterone guidance / unscaled ABE, EMA’s Method C) to me. Only then one may run into convergence issues. No problem with EMA’s crippled models (Methods A [subjects fixed] and B [subjects random]).

❝ … having 2x more data of one treatment than the other is not good for the estimations. Seems like you give more chances for one treatment to show its "real PK profile". Could I say that?


You can, of course. This forum is not censored. :-D

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