Evaluation of Reference variability [Design Issues]

posted by Nirali  – India, 2009-04-13 11:53  – Posting: # 3515
Views: 2,750

Dear All,

We want to conduct BE replicate study to demonstrate that the within-subject variability for Cmax of the reference compound in the study is >30% for EU regulatory.

To check reference variablity which study design and model shall be used for statistical analysis?

Shall we use 2-period replicate design to assess the inter and intra-subject variability of reference drug, in which reference drug given in both the periods?

Thanks & Regards,

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