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Guidance to develop individual dose recommendations for patients on chronic hemodialysis

Dao, Kim
Livio, Françoise
Pfister, Marc
Published in Expert Review of Clinical Pharmacology. 2017, vol. 10, no. 7, p. 737-752
Abstract In addition to tailored clinical trials in patients on chronic hemodialysis (HD) during drug development, clinician-initiated post-marketing studies and case reports on individual pharmacokinetic (PK) assessments provide an important source of information about drug dialysability and individualized dose recommendations in this vulnerable population. Areas covered: First, factors that may alter drug exposure in HD patients are explained. Second, available regulatory and methodological guidelines for PK assessments in this population are summarized. Third, a 4-step approach is proposed to develop individual dose recommendations for HD patients receiving drugs without data from a PK study: (1) literature search, (2) model-based dosage decisions, (3) validation and refinement through concentration monitoring, and (4) publication of relevant observations. Fourth, clinician-initiated PK assessments and case reports to evaluate and individualize use of drugs in HD patients are reviewed, and recommendations to enhance their quality are discussed. Expert commentary: Guidance on collecting and reporting PK information in individual HD patients is warranted to ensure completeness and consistency of such PK studies. A checklist and template for easy-to-implement PK calculations and pharmacometric modeling is provided to facilitate evaluation and individualization of dosing strategies in these patients.
Keywords ChecklistDose-Response RelationshipDrugDrug DesignHumansModelsBiologicalPharmaceutical Preparations/administration & dosage/metabolismPharmacokineticsPractice Guidelines as TopicRenal Dialysis
PMID: 28447486
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Research group Groupe Desmeules Jules (pharmacologie/toxicologie) (567)
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GOTTA, Verena et al. Guidance to develop individual dose recommendations for patients on chronic hemodialysis. In: Expert Review of Clinical Pharmacology, 2017, vol. 10, n° 7, p. 737-752. doi: 10.1080/17512433.2017.1323632 https://archive-ouverte.unige.ch/unige:99800

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Deposited on : 2017-11-29

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