From Genotype to Dose: Evaluating Pharmacogenomics-Guided Drug Therapy in a Prospective Clinical Trial

 IQR Journal of Pharmacy and Pharmaceutical Sciences

Volume 2, Issue 1, August 2026 

ISSN: 3107-9776 (Online) 

From Genotype to Dose: Evaluating Pharmacogenomics-Guided Drug Therapy in a Prospective Clinical Trial

Sneha Mittal, Student, Pratiksha Institute of Pharmaceutical Sciences, Guwahati.


Abstract

Advances in pharmacogenomics are increasingly integrated into models of precision medicine as inherited genetic variation can impact drug metabolism, drug transport, pharmacodynamic response, therapeutic effectiveness, and risk of adverse drug events. Traditional models of pharmacotherapy have often relied on broad dosing recommendations based on clinical trials at the population level despite large differences that exist between individual patients taking the same medication. Pharmacogenomics-guided drug therapy (PGx) is an alternative that aims to leverage a patient’s genetic information to individualize drug therapy by selecting appropriate drugs and optimizing dosing. This paper discusses how genotype is translated to patient-specific dose in the context of a prospective clinical-trial model and proposes that clinical utility of PGx is linked to not only clinically actionable variants, but also the quality, identity, interoperability, traceability, and governance of clinical data. Recent publications have shown increased interest in pharmacogenomic panel testing, precision dosing, genetically enriched clinical trial design, and pharmacogenomic decision support at the point of care (Mosch et al., 2025; Zhang et al., 2025). However, gaps remain related to data validation, regulatory approval processes, clinical implementation, and equitable representation of populations which may be inhibiting broader adoption. As such, this paper presents a novel model that incorporates genotype along with clinical characteristics, therapeutic drug monitoring, pharmacokinetics, artificial intelligence, and human clinical assessment. Additionally, this paper explores how clinical data managers can help to preserve patient identity and data integrity, incorporating recent discussions around human identity and clinical-trial data management. Trustworthy integration of pharmacogenomics and clinical data may serve as one foundation for safer and more effective precision pharmaceutical care. 

Keywords: pharmacogenomics, precision medicine, clinical trials, individualized dosing, pharmacogenetic testing, clinical data integrity, therapeutic drug monitoring, artificial intelligence, pharmaceutical research, precision pharmacotherapy

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