Bioequivalence and Bioavailability Forum • long half-life and large variability

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

posted by martin – Austria, 2020-07-29 16:57 (11 d 20:52 ago) – Posting: # 21798
Views: 276

Dear all,

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

In short:

pretty long half-life (i.e. replicate designs are out of scope)
huge total variablity (i.e. within + between variability)
total variability is expected to be explained to some degree by some covariates (i.e. including these covariates in the model is expected to lead to a feasable study size)

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

Complete thread:

long half-life and large variabilitymartin 2020-07-29 16:57 [Regulatives / Guidelines]
- long half-life and large variability ElMaestro 2020-07-29 21:24
  - long half-life and large variability martin 2020-07-29 22:49
    - long half-life and large variability ElMaestro 2020-07-30 08:17
      - long half-life and large variability dshah 2020-08-10 06:18