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manusyriac
Junior

India,
2018-09-20 09:45

Posting: # 19293
Views: 560
 

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

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
Hero

Denmark,
2018-09-20 12:19

@ manusyriac
Posting: # 19294
Views: 492
 

 Usage of different lots of RLDs in multistage adaptive studies

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.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
manusyriac
Junior

India,
2018-09-20 13:05
(edited by Ohlbe on 2018-09-20 23:16)

@ ElMaestro
Posting: # 19295
Views: 499
 

 Usage of different lots of RLDs in multistage adaptive studies

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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