manusyriac
☆    

India,
2018-09-20 11:45
(2038 d 13:15 ago)

Posting: # 19293
Views: 2,144
 

 Usage of different lots of RLDs in multistage adaptive studies [Regulatives / Guidelines]

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Hi All,

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.

Thank you.
 
ElMaestro
★★★

Denmark,
2018-09-20 14:19
(2038 d 10:40 ago)

@ manusyriac
Posting: # 19294
Views: 1,834
 

 Usage of different lots of RLDs in multistage adaptive studies

Post reply
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.
—
Pass or fail!
ElMaestro
 
manusyriac
☆    

India,
2018-09-20 15:05
(2038 d 09:55 ago)

(edited by Ohlbe on 2018-09-20 23:16)
@ ElMaestro
Posting: # 19295
Views: 1,820
 

 Usage of different lots of RLDs in multistage adaptive studies

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Thanks for your quick response.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
 
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