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Evaluation of Assumptions Underpinning Pharmacometric Models
Qing-Xi Ooi1, Daniel F B Wright2, Geoffrey K Isbister3
1School of Pharmacy, University of Otago, 63 Hanover Street, Dunedin, 9016, New Zealand. qingxiooi.pmx@gmail.com.
The AAPS Journal
|August 7, 2019
Summary
This study introduces a systematic framework to evaluate assumptions in pharmacometric model development. It categorizes assumptions and provides a decision-making process for model building and use.
Area of Science:
- Pharmacometrics
- Mathematical Modeling
- Drug Development
Background:
- Pharmacometric models are crucial in drug development but rely on unexamined assumptions.
- Lack of routine evaluation for these assumptions can impact model reliability and decision-making.
Purpose of the Study:
- To present a novel framework for the systematic evaluation of assumptions in pharmacometric modeling.
- To categorize assumptions into implicit and explicit types for better identification and assessment.
Main Methods:
- Developed a flowchart for systematic assumption evaluation.
- Classified assumptions as implicit (inherent) or explicit (user-defined).
- Proposed a decision-making process based on impact and probability of assumption violation, leading to 'go'/'no-go' decisions.
Main Results:
- A structured approach to identify, document, and evaluate pharmacometric model assumptions was established.
- The framework was illustrated using assumptions from a warfarin-coagulation protein model.
- A standardized table format for documenting assumptions and evaluation results was proposed.
Conclusions:
- The proposed framework offers a systematic method to address the critical but often overlooked aspect of assumption evaluation in pharmacometrics.
- Further application of this framework across diverse settings is needed to confirm its practicality and value.
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