EMA: ABEL for HVD(P)s, PK metrics [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-09-08 09:05 (82 d 03:43 ago) – Posting: # 21910
Views: 1,017

Thanks For your detailed response.

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.

Thanks.

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