From Pharmacological Informatics to Informational Pharmacology: A Conceptual Shift in Therapeutics

This article offers a conceptual analysis of AI within information pharmacology, exploring its role as both a supportive tool and an autonomous therapeutic factor. It distinguishes between pharmacological informatics (instrumental level) and information pharmacology (ontological level) and proposes criteria for classifying AI systems as information-based medicinal products, focusing on dose-dependent, reproducible, and clinically meaningful effects. The study examines the relationship between material (molecular) and informational therapeutics, highlighting their conceptual connections and ontological distinctions. Comparative analysis of pharmacodynamics and pharmacokinetics elucidates therapeutic windows, dosing, efficacy, and risk for information-based interventions. The role of formal models in standardization, prediction, and regulatory evaluation is discussed. Finally, legal and ethical considerations for digital medicine and increasingly autonomous therapeutic systems are addressed, emphasizing the emerging framework for safely integrating AI into clinical practice.