Steady State Study Criteria for Pre-dose [Regulatives / Guidelines]

posted by sandipmumbai – India, 2012-10-16 11:13 (5000 d 16:29 ago) – Posting: # 9423
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Hi,

I have query regarding Steady State study.
  1. As per EMEA guidelines, if pre-dose concentration of the analytes are detected, the subject’s data can be included in the statistical analysis, without adjustment, if they represent less than or equal to 5% of the respective Cmax value of the corresponding period. If it is greater than 5% of the Cmax value, the subject will be dropped from all bioequivalence evaluations.
  2. Is the above criteria of pre-dose will be apply for steady state study?

Regards,
Sandy.......

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