manusyriac
☆    

India,
2018-09-20 09:45
(998 d 19:40 ago)

Posting: # 19293
Views: 1,721
 

 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
★★★

Denmark,
2018-09-20 12:19
(998 d 17:06 ago)

@ manusyriac
Posting: # 19294
Views: 1,481
 

 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.

Pass or fail!
ElMaestro
manusyriac
☆    

India,
2018-09-20 13:05
(998 d 16:20 ago)

(edited by Ohlbe on 2018-09-20 23:16)
@ ElMaestro
Posting: # 19295
Views: 1,472
 

 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]
Activity
 Admin contact
21,518 posts in 4,498 threads, 1,524 registered users;
online 21 (0 registered, 21 guests [including 6 identified bots]).
Forum time: Tuesday 05:26 CEST (Europe/Vienna)

I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5