long half-life and large variability [Regulatives / Guidelines]
❝ There are two types of covariates (type 1: continous = subject specfic values; and type 2: categorical variable with a few levels).
Type 2 sounds like the very thing that I would call a fixed factor.
❝ At the first glance a different regulatory pathway might be worth considering based on a PK or exposure similarity evalulation as in such a case there could be more flexibility regarding acceptance of statistical models used to test for equivalence in PK metrics.
❝ Happy to get your thoughts on this idea.
I would always recommend to approach regulators for a discussion. They will always listen but not always agree.
Injectable? Sometimes surface area or body weight is reasonable for exposure modeling. That's a covariate in the word's best sense As in, a continuous variable. If multiple periods or longitudinal study, a covariates like bw may change over time.
Pass or fail!
- long half-life and large variability martin 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 Achievwin 2020-08-12 15:22
- long half-life and large variability Helmut 2020-08-12 15:53