Bioequivalence and Bioavailability Forum

Dear All

i am having doubt in calculation of intra-subject variability using 90% CI from this below formula.
pls refer the link for the formula. http://bebac.at/lectures/Moscow2012Con.pdf.

i just compared the calculation of intrasubject variability from literature(Reference literature from EMEA(public assessment Report): http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001053/WC500031168.pdf.) that already have the value of 90% CI, Number of subject and IntraCV and i manually calculated the intrasubject CV from 90% CI and No. of subject from the formula.

Comparison of EMEA IntraCV with the manual Calculation Intracv

Parameters  - From  EMEA Literature - From Manual Cal.Formula
Cmax        -       47              -      46.78
AUCt        -       41              -      40.88
AUCinf      -       40              -      46.17

from that calculation i am getting Same intraCV for cmax and AUCt but for AUCinf the values are showing difference.


so pls guide me.

thanks in advance