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Updated: Jan 20, 2026

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A modelling framework for improved design and decision-making in drug development.

Stig Johan Wiklund1

  • 1Captario AB, Göteborg, Sweden.

Plos One
|August 29, 2019
PubMed
Summary

Improving drug development efficiency requires a holistic, model-based approach. This strategy integrates all program phases and acknowledges uncertainty, leading to better decisions and increased value in pharmaceutical innovation.

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Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Decision Analysis

Background:

  • Drug development is a high-risk, costly, and time-consuming process.
  • Current strategies often optimize development stages in isolation, ignoring critical uncertainties.
  • Inefficiencies in drug development lead to significant financial and temporal losses.

Purpose of the Study:

  • To propose a holistic, model-based approach for optimizing drug development.
  • To enhance decision-making capabilities by integrating all program aspects.
  • To address the limitations of traditional, fragmented development strategies.

Main Methods:

  • Implementing an integrated, holistic view of the entire drug development program, including post-launch activities.
  • Explicitly incorporating all relevant sources of uncertainty into the development model.
  • Utilizing computer simulations for evaluating program options and providing quantitative decision support.

Main Results:

  • The model-based approach facilitates the generation of superior program options.
  • Quantitative decision support leads to more value-adding decisions.
  • Applications demonstrate significant value addition to drug development projects.

Conclusions:

  • A holistic, model-based strategy is crucial for improving drug development efficiency and decision-making.
  • Integrating all program phases and uncertainties maximizes potential gains.
  • This approach enhances the overall value and success rate of pharmaceutical projects.