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Dear All
We have conducted a 28 day oral Pk study (50 mg /kg /day) and on day
28 the PK data is as follows
Time (h) Conc (ug/mL)
Predose BQL (LLOQ-0.005 ug/mL)
1.5 3.7
5.0 4.2
8.0 3.5
24.0 0.16
When we calculated AUC (0-t) through WinNonlin (5.2) by NCA, BQL value
was considered as 'zero' by the software and calculated the AUC value
approximately 57 ug.h/mL.
When we used the steady state option in NCA in WinNonlin the BQL was
considered as 0.16 ug/mL (lowest in the dosing interval) and calculated
AUC (higher compared to the earlier approach)
My questions are
1. What is the best approach in this scenario?
2. Whether the BQL values at predose (day n) should be
considered as zero / lowest in the dosing interval / should we avoid
the partial area as such between the predose and the first observed
data point (i.e. at 1.5 h)?
Thanks in advance.
Best regards
Maneesh Mehta
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dear maneesh,
Please follow the evidence based PK practice.
Are you sure that your drug has reached steadystate/
your data shows it has not reached!
How can the pre-dose (before 24.0 hr sample) be less than 24.0 hr
concentration if the dosing interval is 24 hour?
Anyway first option is quite acceptable.
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