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Dear All,
I would like to know how to calculate AUCreftmax?
Why we want to calculate this parameter?
Thanks & Regards,
Neethu Johney
Biostatistician
Manipal Acunova
Bangalore- 560066
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I'm not sure what you mean by that. I am guessing you have a compound whose time to effect is important. Thus, you want to calculate the AUC of a reference compound up to the Tmax. This can be done by taking the population median Tmax and calculating AUC0-Tmax for your reference compound
Of course, your sampling scheme is quite important. See the last paragraph on page 11 and continuation to page 12 of the FDA guidance on BE.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation /Guidances/ucm070124.pdf
Tae
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Hello Neethu,
First you have to calculate Tmax of Reference product for each subject and
then calculate AUC till that Tmax for each subject for both the products
(test & ref). AUCreftmax is calculated when an early time of onset or rapid
rate of absorption plays important role to establish Bioequivalence. Regards
Hitesh
Biostatistician
BA Research India Ltd.
[And maybe a drug with a (very) long half-life such that sampling to multiple half-lives would be impractical? - db]
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Dear Neethu,
Please refer to guidance how to calculate the calculate AUCreftmax
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/notic e_rapidonset_avis_apparitionrapide-eng.pdf
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/dra ft_ebauche_bios-eng.pdf
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/dra ft_ebauche_cbs-eng.pdf
Vishnu
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