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RegisterTruncate 72 hrs for ANVISA [Regulatives / Guidelines]
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.
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
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
Complete thread:
- Truncate 72 hrs for ANVISA Dr RCG 2013-08-30 06:58
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- Truncate 72 hrs for ANVISAdrgunasakaran1 2013-08-31 05:46
- Truncate 72 hrs for ANVISA Mauricio Sampaio 2013-09-02 06:43
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