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I have some queries regarding the EMEA guidlines on "Modified release
oral and Transdermal dosage forms".
In the section 4.1.2 Variability of the above mentioned guidline it is
"It may be valuable to assess the intra-individual variability. This
could be achieved by either repeated measurement of the concentration
profile at steady state or by performing a single dose study with
Now my questions are
1) How repeated measurement of concentration profile at steady state can
2) How intra-individual variability can be measured by repeated
measurement of concentration profile at steady state as mentioned in
guideline. Please provide some detail regarding its statistical aspect.
3) What should be the appropriate study design in above case?
Waiting for your invaluable replies.
Thanks & Regards,
Ravi Shankar Pandey
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