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

posted by Pharma_88 – India, 2020-09-08 09:05 (18 d 01:10 ago) – Posting: # 21910
Views: 794

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.


Complete thread:

 Admin contact
21,076 posts in 4,394 threads, 1,468 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Saturday 10:15 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz