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pash413 ★ India, 2012-02-03 13:15 (5242 d 01:20 ago) Posting: # 8049 Views: 2,517 |
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Deal All 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. |
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drgunasakaran1 ★★  2012-02-04 06:31 (5241 d 08:04 ago) @ pash413 Posting: # 8051 Views: 2,177 |
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Dear Mr.Pash413, The primary Pharmacokinetic parameters need to estimated for Endogenous substances are Cmax, AUC0-t and AUC0-inf. Bioequivalence criteria need to evaluated for Cmax, AUC0-t and AUC0-inf. FDA will not usually accept, if you submit AUC0-inf data only as supportive evidence excluding from Bioequivalence criteria. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz