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RegisterBioanalysis discontinued subject [Regulatives / Guidelines]
Hello,
Since I've started to work with BE, I've always seen in protocol that bioanalysis was required to be performed for samples of subject discontinued due to AE or emesis, but could be omitted for subjects discontinued for other reasons. I'm looking for the specific guidance (EMA, FDA) related to this requirement. Can someone help ?
Joe
Since I've started to work with BE, I've always seen in protocol that bioanalysis was required to be performed for samples of subject discontinued due to AE or emesis, but could be omitted for subjects discontinued for other reasons. I'm looking for the specific guidance (EMA, FDA) related to this requirement. Can someone help ?
Joe
Complete thread:
- Bioanalysis discontinued subjectJohanne 2018-08-02 00:31 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioanalysis discontinued subject Helmut 2018-08-02 02:02
- Bioanalysis discontinued subject ElMaestro 2018-08-02 11:14
Ing. Helmut Schütz