"Does the committee agree that..."
Does the committee agree that renal impairment can affect metabolism or transport of drugs that are substrates of metabolizing enzymes and transporters?
"Does the committee agree with..."
Does the committee agree with the recommended methods of determining renal function and the proposed stratification of patients based on renal function?
3. What comments or recommendations does the committee have on applying the following decision tree (Figure 1) to the determination of when a renal impairment study is needed for an investigational drug?
4. What studies in hemodialysis patients does the committee recommend for drugs intended for chronic administration?