vinodvasala
☆    

India,
2021-04-13 15:27
(1105 d 18:27 ago)

Posting: # 22307
Views: 2,649
 

 Retention samples [Regulatives / Guidelines]

Post reply
Hi Sir,

Could you please tell me what is the retention sample for USFDA, Canada, EC, WHO and Anvisa for BA&BE studies
 
dshah
★★  

India/United Kingdom,
2021-04-13 21:07
(1105 d 12:46 ago)

@ vinodvasala
Posting: # 22308
Views: 2,166
 

 Retention samples

Post reply
Dear Vinodvasala!

Please search in forum for previous discussions  ,  ,  . In general as per Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)- 30 units for Drug Products Manufactured in Single-Dose Units or 3 units for Drug Products Manufactured in Multi-Dose Units for US regulatory and 300 units for 5X testing (safer approach).
Regards,
Dshah
 
UA Flag
Activity
 Admin contact
22,990 posts in 4,826 threads, 1,665 registered users;
56 visitors (0 registered, 56 guests [including 1 identified bots]).
Forum time: 09:54 CEST (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

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