Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
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Case Study 2 — Step 2:<br />
Simulate competitor trial arms that match the NCE data<br />
Enables comparison across populations <strong>and</strong> studies,<br />
account<strong>in</strong>g for unique comb<strong>in</strong>ations <strong>of</strong> dose, basel<strong>in</strong>e<br />
values, percent <strong>of</strong> naïve patients, run-<strong>in</strong> length.<br />
Naive pts<br />
Non-naive pts<br />
Placebo<br />
FPG<br />
Placebo<br />
Run-<strong>in</strong><br />
T=8<br />
Placebo<br />
Low Dose<br />
High Dose<br />
Low Dose<br />
High Dose<br />
Lowest FPG<br />
Lowest FPG<br />
Start<br />
Drug<br />
T=0<br />
Time (weeks)<br />
Start<br />
Drug<br />
T=0<br />
Time (weeks)<br />
Placebo<br />
HbA1c<br />
Placebo<br />
Low Dose<br />
High Dose<br />
Low Dose<br />
High Dose<br />
Lowest HbA1c<br />
Lowest HbA1c<br />
Slide 28<br />
Start<br />
Drug<br />
T=0<br />
Time (weeks)<br />
© Tripos, L.P. 2011 All Rights Reserved<br />
Start<br />
Drug<br />
T=0<br />
Time (weeks)
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