Achievwin
★★  

US,
2023-02-06 14:40
(876 d 04:21 ago)

Posting: # 23440
Views: 3,299
 

 Documentation of SS for LAI [Design Issues]

Hi:

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.
dshah
★★  

India,
2023-02-28 17:50
(854 d 01:11 ago)

@ Achievwin
Posting: # 23480
Views: 2,331
 

 Documentation of SS for LAI

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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