Guidance to develop individual dose recommendations for patients on chronic hemodialysis

Expert Rev Clin Pharmacol. 2017 Jul;10(7):737-752. doi: 10.1080/17512433.2017.1323632. Epub 2017 May 22.


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: Renal replacement therapy; case reports; end-stage renal disease; hemodialysis; impaired kidney function; modelling; pharmacokinetics; pharmacometrics; systematic review.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Checklist
  • Dose-Response Relationship, Drug
  • Drug Design
  • Humans
  • Models, Biological*
  • Pharmaceutical Preparations / administration & dosage*
  • Pharmaceutical Preparations / metabolism
  • Pharmacokinetics
  • Practice Guidelines as Topic
  • Renal Dialysis*


  • Pharmaceutical Preparations