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RegisterDifferent method in single ANDA [Bioanalytics]
Dear Compliance,
do I understand it correctly that you have two studies, one fasting and one fed, and in each study a different method was used? In this case I would not expect any problems if the analytical methods are both validated according to the respective guidelines.
With kind regards,
Jan
do I understand it correctly that you have two studies, one fasting and one fed, and in each study a different method was used? In this case I would not expect any problems if the analytical methods are both validated according to the respective guidelines.
With kind regards,
Jan
Complete thread:
- Different method in single ANDA Compliance 2015-02-18 04:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different method in single ANDAjanmacek 2015-02-18 09:06
- Different method in single ANDA Compliance 2015-02-18 11:16
- Different method in single ANDAjanmacek 2015-02-18 09:06
Ing. Helmut Schütz