Answer Happy

Question 39 1 pts According to the FDA Guidance for Industry, Pharmacokinetics in Patients with Impaired Renal Function (Sept 2020), which of the following is true of a stand-alone study to evaluate the effect of renal impairment on drug pharmacokinetics? A healthy control group used for comparison does not need to be overall similar to the subjects with renal impairment with respect to demographic characteristics such as age, sex and race Need not consider non-renal metabolic and transport pathways of drug elimination because they are rarely affected by renal impairment Must always include a group with end-stage renal disease on hemodialysis Assumes that drug exposure-response relationships for efficacy and safety are little affected by renal impairment Is not required to be done if less than 30% of the parent drug is excreted unchanged into urine