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Kidney Safety Assessment: Current Practices in Drug Development

Sean P Troth1, Frank Simutis2, Gary S Friedman3

  • 1Merck Research Laboratories, Department of Safety Assessment and Laboratory Animal Resources, West Point, PA.

Seminars in Nephrology
|March 5, 2019
PubMed

Insights

Identifying kidney toxicity early in drug development is crucial. This research reviews current strategies and industry practices for assessing and mitigating drug-induced kidney injury, aiming to improve drug safety.

Area of Science:

  • Pharmacology and Toxicology
  • Drug Development
  • Renal Physiology

Background:

  • The kidney is highly susceptible to drug-induced toxicity due to its metabolic and filtration functions.
  • Early identification of nephrotoxic compounds is essential for successful drug development.
  • Translational biomarkers for monitoring kidney toxicity are increasingly recognized in later drug development stages.

Purpose of the Study:

  • To provide perspective on the challenges of kidney safety assessment in drug development.
  • To review advancements in kidney safety strategies and model systems.
  • To offer insights into industry practices for de-risking nephrotoxic compounds.

Main Methods:

  • Literature review of kidney safety assessment tools and strategies.
  • Analysis of case examples in pharmaceutical drug development.
  • Presentation of survey results from the Innovation and Quality Drug Safety consortium on industry experiences.

Main Results:

  • Despite progress, a consensus on best practices for kidney safety assessment across drug development phases is lacking.
  • Industry survey reveals diverse approaches to compound attrition and de-risking.
  • Case examples illustrate successful de-risking scenarios for kidney toxicity.

Conclusions:

  • There is a critical need for standardized and reliable methods for early kidney safety evaluation.
  • Further research and collaboration are needed to establish best practices in drug-induced kidney injury assessment.
  • Improved strategies can enhance decision-making and reduce attrition in drug pipelines.
Keywords:
Nephrotoxicitybiomarkersdrug attritiondrug safetykidneyprediction

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