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Tipranavir NDA 21-814:
Exposure Response Analysis
Jenny J Zheng, Ph.D.
Pharmacometrics Reviewer
Office of Clinical Pharmacology and Biopharmaceutics
CDER, FDA
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The measurement of tipranavir c
min
and viral IC
50
as an option for the individualization of tipranavir/ritonavir dosing
3
TPV C
min
, IC
50
, T20 co-administration significantly influence viral response
4
C
min
in Phase 2 and Phase 3 at Different Doses
5
Inhibitory quotient displays high
between-patient variability
6
Probability of grade 3 or 4 ALT toxicity increases with higher tipranavir C
min
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Possible Therapeutic Drug Monitoring Strategy
8
The measurement of tipranavir c
min
and viral IC
50
as an option for the individualization of tipranavir/ritonavir dosing
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