Guidance to develop individual dose recommendations for patients on chronic hemodialysis.

Details

Serval ID
serval:BIB_6988A7B73890
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Guidance to develop individual dose recommendations for patients on chronic hemodialysis.
Journal
Expert review of clinical pharmacology
Author(s)
Gotta V., Dao K., Rodieux F., Buclin T., Livio F., Pfister M.
ISSN
1751-2441 (Electronic)
ISSN-L
1751-2433
Publication state
Published
Issued date
07/2017
Peer-reviewed
Oui
Volume
10
Number
7
Pages
737-752
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
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.

Pubmed
Web of science
Create date
09/05/2017 19:54
Last modification date
20/08/2019 15:24
Usage data