vinodvasala
☆    

India,
2021-04-13 13:27
(488 d 18:53 ago)

Posting: # 22307
Views: 2,181
 

 Retention samples [Regulatives / Guidelines]

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 19:07
(488 d 13:12 ago)

(edited by dshah on 2021-04-13 19:19)
@ vinodvasala
Posting: # 22308
Views: 1,768
 

 Retention samples

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
22,301 posts in 4,667 threads, 1,585 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Monday 08:20 CEST (Europe/Vienna)

Science… never solves a problem
without creating ten more.    George Bernard Shaw

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