|
1
|
|
|
2
|
- Does the committee agree that renal impairment can affect metabolism or
transport of drugs that are substrates of metabolizing enzymes and
transporters?
|
|
3
|
- Does the committee agree with the recommended methods of determining
renal function and the proposed stratification of patients based on
renal function?
|
|
4
|
- 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?
|
|
5
|
|
|
6
|
- 4. What studies in hemodialysis patients does the committee recommend
for drugs intended for chronic administration?
|
Notes
