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Hi All,
Question regarding the USFDA guideline for repeating a BE study.
The study is a normal two-way crossover bioequivalence study. The study failed because the molecule degraded during bio-analysis and long-term stability was not proven. Because the Test product is from same exhibit batch a repeat study is demanded by sponsor.
On what grounds can the study be repeated, or, what is the justification to repeat the study, such that it is acceptable by the FDA regulatory.
Thank you
Ram
Question regarding the USFDA guideline for repeating a BE study.
The study is a normal two-way crossover bioequivalence study. The study failed because the molecule degraded during bio-analysis and long-term stability was not proven. Because the Test product is from same exhibit batch a repeat study is demanded by sponsor.
On what grounds can the study be repeated, or, what is the justification to repeat the study, such that it is acceptable by the FDA regulatory.
Thank you
Ram
Complete thread:
- Repeating BE studyRam14 2014-12-25 18:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Repeating BE study ElMaestro 2014-12-25 21:00
- Repeating BE study Ram14 2014-12-26 08:38
- Repeating BE study Ohlbe 2015-01-05 12:26
- Repeating BE study Ram14 2015-01-05 17:31
- Repeating BE study Ohlbe 2015-01-05 18:34
- Repeating BE study Ram14 2015-01-06 07:40
- Repeating BE study Ohlbe 2015-01-05 18:34
- Repeating BE study Ram14 2015-01-05 17:31
- Repeating BE study Ohlbe 2015-01-05 12:26
- Repeating BE study Ram14 2014-12-26 08:38
- Repeating BE study ElMaestro 2014-12-25 21:00
Ing. Helmut Schütz