Bioequivalence and Bioavailability Forum • Scaling of Cmin

Scaling of Cmin [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2014-12-10 18:21 (3845 d 05:53 ago) – Posting: # 14049
Views: 15,126

Dear kumarnaidu

❝ 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

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