vinodvasala
☆    

India,
2021-04-13 15:27
(1103 d 00:00 ago)

Posting: # 22307
Views: 2,640
 

 Retention samples [Regulatives / Guidelines]

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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
(1102 d 18:20 ago)

@ vinodvasala
Posting: # 22308
Views: 2,159
 

 Retention samples

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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
 
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