Bioequivalence and Bioavailability Forum • Truncate 72 hrs for ANVISA

Dr RCG
☆

2013-08-30 08:58
(4681 d 00:45 ago)

Posting: # 11391
Views: 3,595

Truncate 72 hrs for ANVISA [Regulatives / Guidelines]

Dear all Pls guide for BE ANVISA submission:
In BE of FDC of two molecules, one molecule is having half life more than 24 hrs, can we truncate upto 72 hrs.
And for second molecule, half life is less than or equal to 24 hrs, can we take last blood collection time point upto 96 hrs.
For bioequivalence criteria for one molecule can I consider Cmax and AUC0-72 and for second molecule can I consider Cmax and AUC0-t.
Will ANVISA accept this design.

drgunasakaran1
★★

2013-08-31 07:46
(4680 d 01:58 ago)

@ Dr RCG
Posting: # 11397
Views: 3,028

Truncate 72 hrs for ANVISA

Post reply

Dear Dr RCG,

As per ANVISA Resolution - RE nº 1170 of 19 May 2006, in case of active ingredients that present a long elimination half life (greater than 24h), an alternative collection schedule of up to 72 hours that makes it possible to determine the area under the truncated curve in its primary packaging, in bulk or a finished product (AUCO-72) may be used.

Hence, you can truncate AUC at 72 hrs for the molecule with half life more than 24 hrs and go for 96 hrs blood sample collection for molecule less than 24 hrs half life.

ANVISA will accept the above design.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Mauricio Sampaio ★ Brazil, 2013-09-02 08:43 (4678 d 01:01 ago) @ Dr RCG Posting: # 11403 Views: 2,689	Truncate 72 hrs for ANVISA Post reply
	Why not? You have two molecules with different half lives. Therefore you are getting two results separately and according statistical criteria both results must respect the range of 80 - 125%. Just the only difference will be the parameter AUC 0-inf that is not applied to cronograms with AUC truncate. Remember,...all depends how you described your protocol. Best regards