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Registernecessity of retention samples for pilot BE study [Regulatives / Guidelines]
Dear Ohlbe,
» As pilot trials are not "required for approval", I would understand that retention samples are not needed for pilot studies. But I'm not a specialist of FDA regulations and John may have a different interpretation.
Thanks! That's certainly one standpoint to look at the regulatory requirement, and it make sense to me. I guess that I missed this point when I read the CFR. Let's see what else we can have in this forum.
» As pilot trials are not "required for approval", I would understand that retention samples are not needed for pilot studies. But I'm not a specialist of FDA regulations and John may have a different interpretation.
Thanks! That's certainly one standpoint to look at the regulatory requirement, and it make sense to me. I guess that I missed this point when I read the CFR. Let's see what else we can have in this forum.
—
All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- necessity of retention samples for pilot BE study Shuanghe 2019-11-25 13:05 [Regulatives / Guidelines]
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- necessity of retention samples for pilot BE study Ohlbe 2019-11-25 15:16
- necessity of retention samples for pilot BE studyShuanghe 2019-11-25 18:00
- necessity of retention samples for pilot BE study ElMaestro 2019-11-25 17:38
- necessity of retention samples for pilot BE study Shuanghe 2019-11-25 18:42
- necessity of retention samples for pilot BE study nobody 2019-11-26 10:11
- necessity of retention samples for pilot BE study Ohlbe 2019-11-25 15:16
Ing. Helmut Schütz