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Can somebody explain "What is truncated AUC approach?"
Aurobindo Pharma Limited
[It is the calculation of AUC from zero to some common time after the
time of peak concentration. Assuming absorption is complete within this
time the analysis can give some good information about the drug
absorption. See the PharmPK topic "Amiodarone biostudy" in the 2003
archive as an example and some references. - db]
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Truncated AUC is the term used to describe the Area under the curve
calculated from time zero to say 72hr. This is described as AUC0-72 hr.
This partial AUC calculation is called AUC truncated. For a very high
half-life drugs we can use this approach for calculation of BE static
instead of AUC0-t or AUC0-inf because it reduces the time, effort and
inconvenience to study subjects. This is acceptable by US-FDA. Only
thing is we need be careful for drugs exhibiting high intrasubject
variability in distribution and clearance parameters. In selecting the
truncated AUC for any molecule sample collection time be adequate to
ensure completion of gastrointestinal transit of the drug product and
absorption of the drug substance.
Ranbaxy Research Labs
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