Monte Carlo Simulations in Pharmaceutical Industry

Instructors

Dr. Mark Chang (AMAG Pharmaceuticals) and Dr. Sandeep Menon (Pfizer).

Half-day course

Total duration: XXX.

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Outline

There is an acute need for the pharmaceutical industry to seek innovative and cost-effective approaches in the overall drug development due to the rising costs. Monte Carlo (MC) Simulations have started playing a critical role during this evolutionary process. MC is the technique of simulating a dynamic system or process using a computer program. This Instant Short Course provides an overview of MC simulations with simple examples, including clinical trial simulation (CTS), prescription drug commercialization, molecular design and simulation, disease modeling and biological pathway and PK/PD simulations. The topics include

  • Model building to translate a clinical trial problem into a CTS problem.
  • Execution to implement the simulation.
  • Interpretation to interpret and utilize the simulation results.

Examples of classic and adaptive trial simulations and a simulation study to optimize adaptive design criteria will be discussed. Simulations examples and case studies will be presented for designing Phase I, II, Seamless Phase I/II, Seamless Phase II/III and Phase III trials. Attendees will learn the overall landscape of MC and basic simulations techniques necessary to carry out simulation effectively.

Live course

This Instant Short Course is based on a full-day live course which has been offered at the FDA/Industry Statistics Workshop.

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