long half-life and large variability [Regulatives / Guidelines]

posted by martin  – Austria, 2020-07-29 18:57 (1806 d 11:42 ago) – Posting: # 21798
Views: 4,719

Dear all,

I would appreciate the forum members thoughts on the following situation.

In short:My interpretation of regulatoy guidelines: adding additional fixed effect factors to the factors mentioned in the guidelines is typically considered as not acceptable by regulators.

best regards & looking forward to some ideas to potentially address this situation

martin

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