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Mahesh M ★ India, 2014-06-03 10:46 (4403 d 07:37 ago) Posting: # 13029 Views: 3,108 |
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Dear All, “The EWP recommends that the bioequivalence acceptance criteria for tacrolimus should be [90-111%] for AUC and [80-125%] for Cmax.” What is the mean of AUC only in it? Is it only AUC 0-t or AUC0-t and AUC0-inf both? In Sirolimus product specific guidance by EMA clearly mention: 80.00– 125.00 for Cmax and 90.00-111.00 for AUC0-t Regards M |
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Ohlbe ★★★ France, 2014-06-03 12:04 (4403 d 06:19 ago) @ Mahesh M Posting: # 13031 Views: 2,619 |
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Dear Mahesh, ❝ “The EWP recommends that the bioequivalence acceptance criteria for tacrolimus should be [90-111%] for AUC and [80-125%] for Cmax.” I would understand it exactly the same way as sirolimus: the 90 % CI for AUC0-t should fall within 90.00 – 111.00. ❝ Is it only AUC 0-t or AUC0-t and AUC0-inf both? AUC0-inf is not a decision criterion in the EU. I would say only AUC0-t. — Regards Ohlbe |
Ing. Helmut Schütz