Bioequivalence and Bioavailability Forum • PK time points

Vaibhav
☆

India,
2022-06-23 23:31
(1054 d 21:17 ago)

Posting: # 23077
Views: 2,785

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, 2022-06-24 13:29 (1054 d 07:19 ago) @ Vaibhav Posting: # 23078 Views: 2,191	PK time points Post reply
	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