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Kidney function considerations critical when assessing drugs in clinical trials

Kidney function can affect the potency and metabolism of drugs that are eliminated by the kidneys or other pathways, but little information is available on how to interpret the effects of kidney function on the benefits and risks of drugs in development.

Kidney function can affect the potency and metabolism of drugs that are eliminated by the kidneys or other pathways, but little information is available on how to interpret the effects of kidney function on the benefits and risks of drugs in development. A new review highlights important considerations when designing clinical studies in individuals with kidney disease, and it highlights techniques such as mathematical modeling tools that will help provide optimal dosing recommendations in these patients. “During clinical development, a stand-alone clinical study that assesses the pharmacokinetics of drugs in subjects with kidney disease is typically conducted, and dosing recommendations

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