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RegisterUsage of different lots of RLDs in multistage adaptive studies [Regulatives / Guidelines]
Hi manusyriac,
» Can we use different lots of RLDS in multistage studies as the study design requires more than 2 years of shelf-life for RLDs. If it is possible please help me to find any relevant regulatory guidance for the same.
Without being absolutely sure I think this would be ok with most EU authorities for the reasons you state. Less convinced about how HC or FDA or PMDA would see it.
Note that in your case batch and stage will have the same meaning for the product(s) in question.
» Can we use different lots of RLDS in multistage studies as the study design requires more than 2 years of shelf-life for RLDs. If it is possible please help me to find any relevant regulatory guidance for the same.
Without being absolutely sure I think this would be ok with most EU authorities for the reasons you state. Less convinced about how HC or FDA or PMDA would see it.
Note that in your case batch and stage will have the same meaning for the product(s) in question.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Usage of different lots of RLDs in multistage adaptive studies manusyriac 2018-09-20 09:45 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Usage of different lots of RLDs in multistage adaptive studiesElMaestro 2018-09-20 12:19
- Usage of different lots of RLDs in multistage adaptive studies manusyriac 2018-09-20 13:05
- Usage of different lots of RLDs in multistage adaptive studiesElMaestro 2018-09-20 12:19
Ing. Helmut Schütz