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Design Optimization

PK sparse sampling scheme optimization for phase III clinical trial in Oncology


After the phase I/II, the sponsor is designing the phase III clinical trial of an antisense oligonucleotide in cancer patients. 

Question of Interest

Is it possible to develop a solid population pharmacokinetic model using phase I/II data to design a sparse sampling scheme for phase III clinical trials?


Nonlinear mixed-effects modeling was used to build the pharmacokinetic model with phase I/II data. An optimization algorithm was used to find the optimal sampling scheme. 


A target-mediated drug disposition model best described phase I/II clinical trial data. Optimal sampling scheme required few samples per individual.  


  • Reduce the cost of the phase III clinical trial through PK samples optimization.
  • Improve the understanding of the drug properties in a larger patient’s population.
  • Support to regulatory submission 

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