Documentation of SS for LAI [Design Issues]

posted by dshah  – India/United Kingdom, 2023-02-28 17:50 (364 d 09:00 ago) – Posting: # 23480
Views: 968

Hi Achievwin!
Great question!

❝ 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?


Are you referring to Guidance on the Administration to Adults of Oil-based Depot and other Long-acting Intramuscular Antipsychotic Injections?

Regards,
Divyen

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