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

posted by kumarnaidu – Mumbai, India, 2014-11-27 13:53 (3410 d 03:04 ago) – Posting: # 13930
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❝ 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?:confused:

Kumar Naidu

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