Status Toward the Implementation of Precision Dosing in Children
- PMID: 34185896
- DOI: 10.1002/jcph.1830
Status Toward the Implementation of Precision Dosing in Children
Abstract
Precision dosing is progressing beyond the conceptual and proof-of-concept stages toward implementation. As the availability of dosing algorithms, tools, and platforms increases, so do the investment in technology services and actual implementation of clinical services offering these solutions to patients. Nowhere is this needed more than in pediatric populations, which are still reliant on adult drug development and bridging strategies to support dosing, often in the absence of actual dose-finding studies in the target pediatric population. Still, there is more work to be done to ensure that proper governance of these services is maintained, and that sustainability of these early implementations is guided by new science as it evolves and meaningful outcome data to confirm that such services deliver on both clinical and economic return on investment. In addition, the field should ensure that all approaches beyond a therapeutic drug monitoring-driven, pharmacokinetic-centric approach should be considered as the tools and services evolve, especially when pediatric-specific pharmacokinetic/pharmacodyamic and pharmacogenetic data are available and shown to be useful to guide dosing. This review evaluates current pediatric precision dosing efforts, highlighting their utility, longevity, and sustainability and assesses the current process for implementing such approaches examining current barriers that stand in the way of broader implementation and the stakeholders that must engage to ensure its ultimate success.
Keywords: MIPD; pediatrics; precision dosing.
© 2021, The American College of Clinical Pharmacology.
References
-
- Gonzalez D, Rao GG, Bailey SC, et al. Precision dosing: public health need, proposed framework, and anticipated impact. Clin Transl Sci. 2017;10:443-454.
-
- Guidance for Industry. General consideration for pediatric pharmacokinetics studies for drugs and biological products. December 2014. https://www.fda.gov/media/90358/download. Accessed December 27, 2020.
-
- Breitkreutz J. European perspectives on pediatric formulations. Clin Ther. 2008;30(11):2146-2154.
-
- Anoshiravani A, Gaskin G, Kopetsky E, Sandborg C, Longhurst CA. Implementing an interoperable personal health record in pediatrics: lessons learned at an academic children's hospital. J Particip Med. 2011;3:e30.
-
- Sofat R, Cremers S, Ferner RE. Drug and therapeutics committees as guardians of safe and rational medicines use. Br J Clin Pharmacol. 2019;86:10-12.
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