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Home » FDA Recommends PK Studies in Kidney-Damaged Patients
FDA Recommends PK Studies in Kidney-Damaged Patients
March 31, 2010
Sponsors should conduct pharmacokinetic (PK) studies in patients with kidney damage as part of clinical development for most investigational drugs intended
for chronic use, an FDA draft guidance says. The PK studies, which observe the effect of the body on a drug, are sometimes needed to provide appropriate
dosing recommendations.