Bioequivalence and Bioavailability Forum

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

posted by kumarnaidu – Mumbai, India, 2014-11-27 13:53 (4229 d 23:16 ago) – Posting: # 13930
Views: 17,109

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

Ok thanks for the reply. But I think for applying widening criteria we need to show CV>30% for reference product and the study should be reference replicate (3way or 4way).
Can we use Pre-dose concentration and Ctau of steady state to show variability?

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 EMEAkumarnaidu 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