Highlights
![]() |
Guidance to develop individual dose recommendations for patients on chronic hemodialysis |
|
Authors | ||
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 | |
Identifiers | PMID: 28447486 | |
Full text |
This document has no fulltext available yet, but you can contact its author by using the form below.
|
|
Structures | ||
Research group | Groupe Desmeules Jules (pharmacologie/toxicologie) (567) | |
Citation (ISO format) | 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 |