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RegisterBioequivalence criteria for endogenous drug [Regulatives / Guidelines]
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For USFDA submission biostudies,is it essential to prove bioequivalence for AUC 0-inf for endogenous drug. Does FDA accepts bioequivalence criteria based on only Cmax and AUC0-t result. As no clarity is given either in USFDA general guidance or in the individual BE guidance for endogenous drug,what should be our approach. As sometime it is not possible to reliably estimate the elimination phase from baseline corrected data, is it OK if we write in our protocol in the prior that the BE will be based on only Cmax and AUC0-t data and the AUC0-inf data shall be submitted as supportive/information purpose.
Kindly advise.
For USFDA submission biostudies,is it essential to prove bioequivalence for AUC 0-inf for endogenous drug. Does FDA accepts bioequivalence criteria based on only Cmax and AUC0-t result. As no clarity is given either in USFDA general guidance or in the individual BE guidance for endogenous drug,what should be our approach. As sometime it is not possible to reliably estimate the elimination phase from baseline corrected data, is it OK if we write in our protocol in the prior that the BE will be based on only Cmax and AUC0-t data and the AUC0-inf data shall be submitted as supportive/information purpose.
Kindly advise.
Complete thread:
- Bioequivalence criteria for endogenous drugpash413 2012-02-03 12:15 [Regulatives / Guidelines]
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- Bioequivalence criteria for endogenous drug drgunasakaran1 2012-02-04 05:31
Ing. Helmut Schütz