Communicating the Value of Pharmacodynamic Modelling in Drug ...
Communicating the Value of Pharmacodynamic Modelling in Drug ...
Communicating the Value of Pharmacodynamic Modelling in Drug ...
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Summary <strong>of</strong> process so far ….<br />
Pre-Cl<strong>in</strong>ical<br />
Data<br />
Safety Trials<br />
Phase II Trials<br />
Competitor<br />
Label<br />
Information<br />
Response<br />
Scientific<br />
Literature<br />
Dose<br />
Population<br />
Model<strong>in</strong>g<br />
Techniques,<br />
Model<br />
qualification<br />
The model summarizes and<br />
quantifies what is known.<br />
The model assumptions detail<br />
what is not known.<br />
PK-PD Models<br />
C(t) = D / V<br />
(Ae -αt + Be -βt )<br />
E(t) = E 0<br />
+ (E max<br />
-E 0<br />
) • C(t)<br />
C(t) + EC 50<br />
+<br />
Model<br />
Assumptions<br />
1.<br />
2.<br />
3.<br />
Simulations<br />
Dimensions <strong>of</strong> Decision Space<br />
• X Endpo<strong>in</strong>ts<br />
• Y <strong>Drug</strong>s/Doses<br />
• Z Covariates<br />
X*Y*Z dimensions<br />
e.g.,1000 simulations/dimension<br />
= [X*Y*Z]* 10 3 data po<strong>in</strong>ts<br />
slide 31<br />
30 May 2008, ARCS<br />
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