Bioequivalence and Bioavailability Forum • Scaling of Cmin

Scaling of Cmin [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2014-12-05 07:03 (3429 d 07:12 ago) – Posting: # 13979
Views: 13,587

Hi Helmut thanks for the comment.

❝ Calculation of the intra-subject variability in multiple dose studies can be based on two consecutive administrations of the same product after reaching steady state.

That means we have to use the 4 way (Fully replicate) method here but with a different sequence RRTT or TTRR

—
Kumar Naidu

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 Cminkumarnaidu 2014-12-05 06:03
        
        Steady state kumarnaidu 2014-12-10 11:15
        
        Steady state nobody 2014-12-10 17:04
        
        Scaling of Cmin Dr_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