Bioequivalence and Bioavailability Forum • Type of study in modified release formulation EMEA

Type of study in modified release formulation EMEA [Regulatives / Guidelines]

posted by nobody – 2014-11-27 12:37 (3811 d 12:32 ago) – Posting: # 13929
Views: 15,377

The guideline allows widening for Ctau,ss as for highly variable drugs. Did you go for that in the protocol? Otherwise...

—
Kindest regards, nobody

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 EMEAnobody 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 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

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