| RENALLY
IMPAIRED SUBJECT POOL
The
staff of CPMI has maintained a population of patients with Renal
Impairment for a number of years. The size of this population varies
but hovers in the 50 -60 patient range at any given time. Most of
these patients result from our intensive screening programs and
are classified as either mild (GFR 50-80 ml/min) or moderately (GFR
20-50 ml/min} impaired. Our ability to recruit severely impaired
patients (GFR less than 30 ml/min) is limited by the fact that most
of these subjects go on a transplant list and are placed on dialysis
in our community but we still have been able to identify and study
enough of these subjects every year. to complete a number of FDA
mandated studies according to the guidance that they have published.
Studies with ESRD patients requires collaboration with a dialysis
center or other investigator.
Guidance for Industry:
Pharmacokinetics in Patients with Impaired Renal Function -
Study Design, Data Analysis, and Impact on Dosing and labeling
1998 US Food and Drug Administration
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