EMA: ABEL for HVD(P)s, PK metrics [Regulatives / Guidelines]
I have a few questions and need your suggestion in this regards.
I have kept following parameters in SS study (IR VS ER).
Primary pharmacokinetic parameters: AUC0-τ,ss
Secondary pharmacokinetic parameters:
Day 01 to 04-Morning dose: Cpd
Day 04 (Morning dose): Cτ,ss, Cmax,ss, Cmin,ss, Tmax,ss, accumulation index, %Fluctuation and Cav
Please correct me.
and also want to know for Cpd and Cτ,ss:
Cpd: All pre-dose samples needs to be considered including profiling day sample or only samples before profiling day?
Cτ,ss: How to calculate it? Whether morning dose of Day 04 is also need to be taken in to account to calculate.
- Design Pharma_88 2020-08-27 16:07 [Regulatives / Guidelines]