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RegisterTruncate 72 hrs for ANVISA [Regulatives / Guidelines]
Dear all Pls guide for BE ANVISA submission:
In BE of FDC of two molecules, one molecule is having half life more than 24 hrs, can we truncate upto 72 hrs.
And for second molecule, half life is less than or equal to 24 hrs, can we take last blood collection time point upto 96 hrs.
For bioequivalence criteria for one molecule can I consider Cmax and AUC0-72 and for second molecule can I consider Cmax and AUC0-t.
Will ANVISA accept this design.
In BE of FDC of two molecules, one molecule is having half life more than 24 hrs, can we truncate upto 72 hrs.
And for second molecule, half life is less than or equal to 24 hrs, can we take last blood collection time point upto 96 hrs.
For bioequivalence criteria for one molecule can I consider Cmax and AUC0-72 and for second molecule can I consider Cmax and AUC0-t.
Will ANVISA accept this design.
Complete thread:
- Truncate 72 hrs for ANVISADr RCG 2013-08-30 06:58
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Truncate 72 hrs for ANVISA drgunasakaran1 2013-08-31 05:46
- Truncate 72 hrs for ANVISA Mauricio Sampaio 2013-09-02 06:43
Ing. Helmut Schütz