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Home » Guidance Focuses on Impact of Impaired Renal Function in Studies, Dosage, Labeling
Guidance Focuses on Impact of Impaired Renal Function in Studies, Dosage, Labeling
Recommendations for drug sponsors to assess the impact of impaired renal function on pharmacokinetics (PK) and/or pharmacodynamics (PD) of an investigational drug, how to determine the recommended dosage, and how to provide appropriate labeling are the subjects of a recently released FDA final guidance.