A pharmacokinetic (PK) study in patients with impaired renal function should be conducted for most drugs intended for chronic use. Since the release of the FDA Guidance on renal PK studies in 2010, various approaches have been used to assess the impact of renal impairment (RI) on investigational drugs.


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Mario Tanguay, Ingrid Freije, Fadi Achkar
Syneos Health Clinique, QC, Canada
Faculty of Pharmacy, Université de Montréal, QC, Canada