Mechanistic computer models to pick combination doses before dosing patients
Simulate how two drugs interact in the body and the tumour to pick a starting dose and schedule, instead of guessing from single-drug data.
Quantitative systems pharmacology models integrate pharmacokinetics, target engagement and downstream biology to predict combination effects and toxicities. FDA's model-informed drug development pathway accepts such models for dose justification. Making a QSP-based schedule proposal a standard component of combination investigational new drug applications would reduce empirical dose-escalation in combinations.
- Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.
- Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
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