Scaling of Cmin [Regulatives / Guidelines]
Dear kumarnaidu
No, you do not need to use a 4 period replicate design: You will have 2 periods and 2 sequences, you just need to dose until you reach steady state, take then the PK profile for the dosing interval and after an afreshed dosing for the consecutive interval.
e.g.:
Kind regards
Dr_Dan
❝ That means we have to use the 4 way (Fully replicate) method here but with a different sequence RRTT or TTRR
No, you do not need to use a 4 period replicate design: You will have 2 periods and 2 sequences, you just need to dose until you reach steady state, take then the PK profile for the dosing interval and after an afreshed dosing for the consecutive interval.
e.g.:
1st dosing drug1
2nd dosing drug1
3rd dosing drug1
4th dosing drug1
5th dosing drug1 -> PK Profile
6th dosing drug1 -> PK Profile
1st dosing drug2
2nd dosing drug2
3rd dosing drug2
4th dosing drug2
5th dosing drug2 -> PK Profile
6th dosing drug2 -> PK Profile
Kind regards
Dr_Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Type of study in modified release formulation EMEA Compliance 2014-03-13 09:43 [Regulatives / Guidelines]
- Type of study in modified release formulation EMEA nobody 2014-03-13 09:52
- Type of study in modified release formulation EMEA fno 2014-03-13 11:16
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 11:02
- Type of study in modified release formulation EMEA nobody 2014-11-27 11:37
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 12:53
- Scaling of Cmin Helmut 2014-11-27 13:47
- Scaling of Cmin kumarnaidu 2014-11-27 15:12
- Scaling of Cmin kumarnaidu 2014-12-05 06:03
- Steady state kumarnaidu 2014-12-10 11:15
- Steady state nobody 2014-12-10 17:04
- Scaling of CminDr_Dan 2014-12-10 17:21
- Scaling of Cmin Helmut 2014-12-10 18:40
- Scaling of Cmin d_labes 2014-12-11 13:09
- Scaling of Cmin Helmut 2014-12-11 14:53
- Scaling of Cmin VStus 2017-02-03 13:04
- Scaling of Cmin zizou 2017-02-03 13:49
- Scaling of Cmin VStus 2017-02-03 15:37
- Scaling of Cmin VStus 2017-02-06 08:55
- Scaling of Cmin zizou 2017-02-03 13:49
- Scaling of Cmin VStus 2017-02-03 13:04
- Scaling of Cmin Helmut 2014-12-11 14:53
- Scaling of Cmin d_labes 2014-12-11 13:09
- Scaling of Cmin Helmut 2014-12-10 18:40
- Steady state kumarnaidu 2014-12-10 11:15
- Scaling of Cmin Helmut 2014-11-27 13:47
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 12:53
- Type of study in modified release formulation EMEA nobody 2014-11-27 11:37
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 11:02