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RegisterComment until 19 May 2014 [Regulatives / Guidelines]
Hi,
According to this guidance, "..."The results of a pilot study can be used as the sole basis to document BA or BE provided the study’s design and execution are suitable and a sufficient number of subjects have completed the study".
I'd like to know if you ever heard about any drug that have been approved by HA (for example a new formulation) based on the results of a pilot BA study (say N=12) rather than a formal BE study?.
Thanks
EB
According to this guidance, "..."The results of a pilot study can be used as the sole basis to document BA or BE provided the study’s design and execution are suitable and a sufficient number of subjects have completed the study".
I'd like to know if you ever heard about any drug that have been approved by HA (for example a new formulation) based on the results of a pilot BA study (say N=12) rather than a formal BE study?.
Thanks
EB
Complete thread:
- New FDA BA/BE guidance for NDAs or INDs fno 2014-03-21 11:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Comment until 19 May 2014 Helmut 2014-03-21 14:10
- Comment until 19 May 2014manu126 2014-05-15 10:52
- Comment until 19 May 2014 Helmut 2014-03-21 14:10
Ing. Helmut Schütz