Study which captures SD and SS PK Profiles [Design Issues]
Hi all,
I seek your opinion on the follow:
If you are being asked to design a PK study to capture single dose and SS PK profiles for a drug product, which dosing and sampling design would you use?
A) On Day 1 dosing, PK sample from time 0 to X (wait a day to a few days or whatever so to capture 1/2 life). Repeat dosing for x number of days to hit steady state (while collecting predose samples to assess SS), then capture SS pk profile from 0 - x hours as per dosing interval (if dosing interval 6 hours then stop at 12 hrs).
B) Capture day 1 PK from time 0 to end of dosing interval, repeat dosing for x # of days (base on dosing interval) to hit SS. On last day of dosing capture time 0 - x (x = whatever hrs needed to fully capture the elimination phase + half-life).
I have seen both designs but I (and my former bosses) prefer method A. The only drawback I see from A is it takes longer time.
Thx
J
I seek your opinion on the follow:
If you are being asked to design a PK study to capture single dose and SS PK profiles for a drug product, which dosing and sampling design would you use?
A) On Day 1 dosing, PK sample from time 0 to X (wait a day to a few days or whatever so to capture 1/2 life). Repeat dosing for x number of days to hit steady state (while collecting predose samples to assess SS), then capture SS pk profile from 0 - x hours as per dosing interval (if dosing interval 6 hours then stop at 12 hrs).
B) Capture day 1 PK from time 0 to end of dosing interval, repeat dosing for x # of days (base on dosing interval) to hit SS. On last day of dosing capture time 0 - x (x = whatever hrs needed to fully capture the elimination phase + half-life).
I have seen both designs but I (and my former bosses) prefer method A. The only drawback I see from A is it takes longer time.
Thx
J
Complete thread:
- Study which captures SD and SS PK Profilesjag009 2020-02-03 20:15 [Design Issues]
- A vs B mittyri 2020-02-03 21:05
- A vs B jag009 2020-02-03 21:29
- ANDA or NDA? Helmut 2020-02-04 00:57
- Modelling mittyri 2020-02-04 09:02
- Modelling Helmut 2020-02-04 12:17
- Modelling: SD+SS mittyri 2020-02-04 12:38
- Modelling Helmut 2020-02-04 12:17
- Modelling mittyri 2020-02-04 09:02
- A vs B mittyri 2020-02-03 21:05