Documentation of SS for LAI [Design Issues]

posted by Achievwin – US, 2023-02-06 14:40 (50 d 16:31 ago) – Posting: # 23440
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Long Acting Injectable products BE guidance require steady state documentation before dosing patients for PK sampling.

My basic questions are

1) how do you document SS (any simple and accepted statistical test?)
2) do you analyze pre-dose samples before the PK-dosing and decide on to dose or add another dosing prior to the PK/BE sampling? or let the study complete and drop the subject (for that period) when the subject fail to meet the SS criteria?

Analyzing pre-dose samples prior to the planned PK dosing in patient studies poses operational challenges and evaluating SS after the entire study completion carries risk of unknown N of patients dropped for SS reasons.

Your guidance is much appreciated.

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