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K2K ★ India, 2012-12-10 10:42 (4522 d 22:36 ago) (edited on 2012-12-10 10:57) Posting: # 9701 Views: 4,418 |
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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.Formulafrom 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 — thanks and regards Karthik |
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d_labes ★★★ Berlin, Germany, 2012-12-10 13:07 (4522 d 20:12 ago) @ K2K Posting: # 9704 Views: 3,658 |
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Dear Karthik your calculations by hand coincide with the CV's obtained from the 90% CIs via R-package PowerTOST, function CVfromCI().I suspect that the CV given in the EMA PAR is simply a typo. The CI for AUC(0-inf) is very near that for Cmax. Thus the CVs should also be. — Regards, Detlew |
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K2K ★ India, 2012-12-11 13:27 (4521 d 19:52 ago) @ d_labes Posting: # 9710 Views: 3,519 |
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❝ I suspect that the CV given in the EMA PAR is simply a typo. ❝ The CI for AUC(0-inf) is very near that for Cmax. Thus the CVs should also be. Dear d_labes thanks for your reply Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] — thanks and regards Karthik |
Ing. Helmut Schütz