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Registeracceptance criteria for tacrolimus [Regulatives / Guidelines]
Dear Mahesh,
I would understand it exactly the same way as sirolimus: the 90 % CI for AUC0-t should fall within 90.00 – 111.00.
AUC0-inf is not a decision criterion in the EU. I would say only AUC0-t.
❝ “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.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- acceptance criteria for tacrolimus Mahesh M 2014-06-03 08:46
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- acceptance criteria for tacrolimusOhlbe 2014-06-03 10:04
Ing. Helmut Schütz