Guidance to develop individual dose recommendations for patients on chronic hemodialysis

摘要: In addition to tailored clinical trials in patients on chronic hemodialysis (HD) during drug development, clinician-initiated post-marketing studies and case reports individual pharmacokinetic (PK) assessments provide an important source of information about dialysability individualized dose recommendations this vulnerable population. Areas covered: First, factors that may alter exposure HD are explained. Second, available regulatory methodological guidelines for PK population summarized. Third, a 4-step approach is proposed develop receiving drugs without data from study: (1) literature search, (2) model-based dosage decisions, (3) validation refinement through concentration monitoring, (4) publication relevant observations. Fourth, evaluate individualize use reviewed, enhance their quality discussed. Expert commentary: Guidance collecting reporting warranted ensure completeness consistency such studies. A checklist template easy-to-implement calculations pharmacometric modeling provided facilitate evaluation individualization dosing strategies these patients.