Vaibhav
☆    

India,
2022-06-23 23:31
(222 d 22:29 ago)

Posting: # 23077
Views: 610
 

 PK time points [Design Issues]

Dear All,
Are the below sampling points adequate for PK profile?
Median Tmax - 6 days
Mean half life: 26 days
Sub cutaneous: single dose
2, 12 and 24 hrs after administration. Additional samples were collected on day 2, 4, 6, 8, 10, 14, 28, 42, 56, 84, 112 and 140 days.
I have taken these time points from an article available in public domain.
Is there any method to calculate sampling point apart from method mentioned in BABE guidelines?
It’s a difficult to calculate time points for drug who has long Tmax and long half life.
Thank you in advance.


Edit: Category changed; see also this post #1[Helmut]
dshah
★★  

India/United Kingdom,
2022-06-24 13:29
(222 d 08:31 ago)

@ Vaibhav
Posting: # 23078
Views: 509
 

 PK time points

Dear Vaibhav!

❝ 2, 12 and 24 hrs after administration. Additional samples were collected on day 2, 4, 6, 8, 10, 14, 28, 42, 56, 84, 112 and 140 days.


I believe that addition of 6 hrs and 12 days would be helpful.
The method of administration would be also critical for impact on burst release.
What is your Cmax and LLOQ-ULOQ?
Regards,
Divyen Shah
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