Advertisement

 

 

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

Guidance to develop individual dose recommendations for patients on chronic hemodialysis.
Author Information (click to view)

Gotta V, Dao K, Rodieux F, Buclin T, Livio F, Pfister M,


Gotta V, Dao K, Rodieux F, Buclin T, Livio F, Pfister M, (click to view)

Gotta V, Dao K, Rodieux F, Buclin T, Livio F, Pfister M,

Advertisement
Share on FacebookTweet about this on TwitterShare on LinkedIn

Expert review of clinical pharmacology 2017 05 2210(7) 737-752 doi 10.1080/17512433.2017.1323632
Abstract
INTRODUCTION
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.

Submit a Comment

Your email address will not be published. Required fields are marked *

thirteen − 6 =

[ HIDE/SHOW ]