TY  - JOUR
T1  - Precision Pharmacotherapy without Exclusion: An Equity-by-Design Framework for Ancestry Diversity, Access, Interpretability, and Clinical Implementation across Health Systems
A1  - Lukas Weber
A1  - Sophie Janssen
A1  - Jonas Richter
A1  - Elena Fischer
JF  - International Journal of Pharmaceutical Research and Allied Sciences
JO  - Int J Pharm Res Allied Sci
SN  - 2277-3657
Y1  - 2025
VL  - 14
IS  - 3
DO  - 10.51847/hBsJHV5cVf
SP  - 11
EP  - 21
N2  - Pharmacogenomics can improve medicine selection and dose individualization, but greater biological precision does not automatically produce equitable care. Exclusion may arise when evidence is derived from narrowly represented populations, genomic associations are transferred without adequate validation, ancestry is replaced by racial or geographic proxies, uncertain variants are treated as definitive, testing is inaccessible, or recommended alternatives cannot be obtained. This article proposes an original Equity-by-Design Framework that treats equity as a property of the complete research-to-care pathway. The architecture links six gates: evidence representation and provenance; assay and interpretation; ancestry-related transferability and dynamic clinical state; access to testing and treatment alternatives; interpretability and shared decision-making; and health-system implementation, monitoring, and governance. An uncertainty record accompanies each decision object, while stop-or-escalate rules prevent progression when evidence coverage, access, interpretability, or monitoring capacity is insufficient. The framework also proposes subgroup-sensitive predeployment evaluation, lifecycle monitoring, and corrective-action authority. Its contribution is the integration of biological transferability, social access, communication, and institutional accountability within one conceptual architecture. Validation would require computational, analytical, clinical, usability, implementation, economic, equity, and governance studies. The framework does not establish the clinical utility of any gene–drug pair, justify ancestry-based prescribing, define universal fairness thresholds, or constitute a validated clinical, regulatory, or deployment pathway.
UR  - https://ijpras.com/article/precision-pharmacotherapy-without-exclusion-an-equity-by-design-framework-for-ancestry-diversity-a-htcai1xq55nxjrs
ER  -