Bioequivalence and Bioavailability Forum

Dear Anu,

❝ Is Everolimus 0.75 mg (Zortress) is under NTI (Narrow Therapeutic Index)?

The Narrow Therapeutic Index (NTI) drugs are those identified as having less than a 2-fold difference between the median lethal and the median effective dose, having less than a 2-fold difference between the minimum toxic and minimum effective concentrations in the blood, and where safe and effective use of the drug requires careful titration and patient monitoring. Everolimus meet these criteria and hence, it will be considered as Narrow Therapeutic Index drug.
Reference: Hornecker JR. Generic drugs: history, approval process and current challenges. US Pharm 2009;34s:26–30.

However, as Mr Helmut said, it is better to ask the concerned regulatory about the NTI status of Everolimus.