TY - JOUR
T1 - Accountable Algorithmic Decision-Making in Pharmaceutical Technology Development
AU - Claire Dupont
AU - Julien Martin
JF - EAMD 3
Y1 - 0
VL - 0
IS - 0
SP - 176
N2 - Algorithmic tools are becoming embedded in pharmaceutical technology development, from formulation screening and excipient selection to process modelling, scale-up prediction, analytical method optimisation, and manufacturing control. These tools increasingly influence decisions that were historically made through human expert judgement, experimental iteration, and quality-system review. This shift creates a governance challenge because algorithmic recommendations may affect product quality, process robustness, patient safety, and regulatory compliance. Yet accountability for such decisions is often distributed ambiguously across data scientists, formulation scientists, process engineers, quality assurance units, regulatory teams, software vendors, and corporate management. The objective of this article is to construct an original governance framework for accountable algorithmic decision-making in pharmaceutical technology development. The framework is designed for settings where artificial intelligence, machine learning, and related computational decision-support tools influence formulation, process, analytical, or quality decisions. The proposed framework argues that accountability must be designed into algorithmic pharmaceutical development rather than retrofitted after model deployment. It defines algorithmic decision types, clarifies accountability triggers, and positions governance as part of the pharmaceutical quality system rather than as a separate digital compliance layer.
UR - https://pubsys.eshragh.co/b722721918
ER -