Physiological Modeling and Simulation-Validation, Credibility, and Application.

Area of Science:

• Physiological modeling
• Computational biology
• Biomedical engineering

Background:

• Widespread disagreement exists regarding the definition and criteria for physiological model validity.
• Ambiguity in model validation hinders the reliable application of models in critical decision-making processes.
• Lack of clear validation standards impacts model credibility and usefulness in clinical, regulatory, and therapeutic design contexts.

Purpose of the Study:

• To critically examine the science of model validation specifically within physiological modeling.
• To investigate how models are used and accepted in other scientific and engineering domains.
• To review historical approaches to physiological model presentation and explore proposed validation frameworks.

Main Methods:

• Review of literature on model validation across different scientific and engineering disciplines.
• Analysis of historical physiological models and their communication to the scientific community.
• Examination of contemporary validation frameworks proposed for physiological models.

Main Results:

• Cross-disciplinary comparison reveals diverse approaches to model acceptance and validation.
• Historical physiological models often lacked explicit validation criteria.
• Several validation frameworks have been proposed recently, but consensus remains elusive.

Conclusions:

• Establishing clear, standardized model validation practices is crucial for advancing physiological modeling.
• Adopting principles from other fields may offer pathways to enhance model credibility.
• Further development and consensus on validation frameworks are needed to ensure reliable use of physiological models.