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Direct Drug Delivery to Kidney via the Renal Artery
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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
Summary
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.
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