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Hi all,
Can anyone let me know if any recently approved drug products that use
MDRD estimated GFR instead of the ClCr (estimated or measured)
category to classify renal insufficient patients (mild, moderate,
severe, ESRD). I am aware that the 1998 FDA guidance recommends ClCr
based classification system but there is a trend leaning towards MDRD
method. If you see any recent papers on this issue please kindly
forward the publication information.
Thanks,
Jack
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Dear Dr Shi,
I am aware of a preliminary concept paper issued by the FDA in March
2008. I am enclosing the link below.
http://www.fda.gov/ohrms/DOCKETS/ac/08/briefing/2008-4351b1-01-FDA.pdf
Kind regards,
Henri MERDJAN
Vice-President, Drug Metabolism and Pharmacokinetics
NOVEXEL SA, Parc Biocitech, 102 avenue Gaston Roussel, 93230
Romainville, Fance
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Jack:
Check out the November issue of Clinical Pharmacology and
Therapeutics....it is largely a "topic" issue on nephropharmacology
and there is a point counter point series of articles on just this
issue in addition to another article from FDAofficials.
Sincerely,
Carol Collins
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Hi Jack,
A new publication from the NIDDK was published in Sept.
CKD and Drug Dosing: Information for Providers
Estimation of Kidney Function for Prescription Medication Dosage in
Adults
http://www.nkdep.nih.gov/professionals/drug-dosing-information.htm
Susan
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I noticed at least one product recently approved avoids categorizing
RI subjects by Mild, Moderate etc. and instead bin them based on CLcr
values, such as described in Nuerontin label. It seems the
stratification suggested by the original FDA guidance is quite flexible.
Thanks to all who provided valuable information.
Jack
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The RI study for that drug was done before 1998, apparently not a good
case of reference.
Jack
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