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Registereverolimus [Regulatives / Guidelines]
Hi Helmut,
Thanks for your esteemed reply.
We wish to carry out BE studies for European Region (EU-EMA) and as per Current effective EU guidance “Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party, Revision 7” does not categorically specify this molecule into NTI category.
Kindly suggest whether we can design a study with a normal acceptable range (80-125)% for Cmax and AUCt or with the acceptance range of (90-111)% considering NTI.
Thanks & Regards
Anu
Thanks for your esteemed reply.
We wish to carry out BE studies for European Region (EU-EMA) and as per Current effective EU guidance “Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party, Revision 7” does not categorically specify this molecule into NTI category.
Kindly suggest whether we can design a study with a normal acceptable range (80-125)% for Cmax and AUCt or with the acceptance range of (90-111)% considering NTI.
Thanks & Regards
Anu
Complete thread:
- NTI Anu 2013-10-03 11:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- everolimus Helmut 2013-10-03 14:07
- everolimusAnu 2013-10-04 06:22
- No list of NTIDs in the EU Helmut 2013-10-04 16:03
- everolimusAnu 2013-10-04 06:22
- NTI drgunasakaran1 2013-10-03 16:09
- everolimus Helmut 2013-10-03 14:07
Ing. Helmut Schütz