Bioequivalence and Bioavailability Forum

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

posted by kumarnaidu – Mumbai, India, 2014-11-27 12:02 (3858 d 06:54 ago) – Posting: # 13928
Views: 15,715

Dear All,
We did BE studies (single dose fast and fed,multiple dose fed) for metformin ER tablets 1000 mg and want to ask-
Can steady state studies marginally failing at Cτ,ss 80.19 (72.8 to 88.34) with ISCV=23.1) be clinically justified for regulatory acceptance if the single dose fast and fed studies are passing for all the parameters including pAUCs?

—
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 EMEAkumarnaidu 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 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

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

Complete thread:

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