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RegisterFDA approach of scaling for NTIs [Regulatives / Guidelines]
Dear all,
FDA has prposed scaling approach in the OGDs of tacrolimus and warfarin.This will lead to narrower than 90-111.11% CI range for the drugs having intraCV less than 10.1%. Residual variability for AUC of warfarin has been reported to be 5.7%. Intrasub CV will be lesser than this. Hence AR will be much narrower. what could be the switchability issue between drug having GMR closer to 90% and other having GMR closer to 110%.what is practical evidence?
AR of 90-111.11% has been acceptable in some regulatories.what could be the consumer risk if the following approach has been followed?
pjs
FDA has prposed scaling approach in the OGDs of tacrolimus and warfarin.This will lead to narrower than 90-111.11% CI range for the drugs having intraCV less than 10.1%. Residual variability for AUC of warfarin has been reported to be 5.7%. Intrasub CV will be lesser than this. Hence AR will be much narrower. what could be the switchability issue between drug having GMR closer to 90% and other having GMR closer to 110%.what is practical evidence?
AR of 90-111.11% has been acceptable in some regulatories.what could be the consumer risk if the following approach has been followed?
- AR-90-111.11% for the dugs having the Intracv equal to or less than 10.1%
- AR- as per FDA scaling method for the intracv 10.1% to 21.42%
- AR- 80-125% for intracv equal to or more than 21.42%
pjs
Complete thread:
- FDA approach of scaling for NTIspjs 2014-01-23 09:07
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Ing. Helmut Schütz