Guidance to develop individual dose recommendations for patients on chronic hemodialysis
|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||Checklist — Dose-Response Relationship — Drug — Drug Design — Humans — Models — Biological — Pharmaceutical Preparations/administration & dosage/metabolism — Pharmacokinetics — Practice Guidelines as Topic — Renal Dialysis|
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|Research group||Groupe Desmeules Jules (pharmacologie/toxicologie) (567)|
|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. https://archive-ouverte.unige.ch/unige:99800|