Exclusion of subjects who are not in SS [Software]

posted by Helmut Homepage – Vienna, Austria, 2007-08-06 22:16 (5531 d 09:42 ago) – Posting: # 966
Views: 17,497

Dear Imran!

» In SS study Cpd Analysis should we calculate SS acheived for each subject, or it should be calulated as a mean of all observation.

As already told in this thread, my personal preferences are always to assess achievement of SS for individual subjects.

» What if a subject 'A' has not acheived SS, sholud the subject be included in the PK analysis.

IMHO this subject should be excluded, because if the subject was not in steady state, the superposition principle of pharmacokinetics is not fulfilled.
You may only make valid statements (about accumulation, etc.) if
AUCinf (single dose) = AUCtau (steady state).

» I understand we calculate ABE, but would be it questioned if any subject is not in SS state.

At least I would do so! :-D

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