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Anu ★ India, 2013-10-03 13:00 (4241 d 10:37 ago) Posting: # 11593 Views: 5,899 |
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Hi all, Greetings! Is Everolimus 0.75 mg (Zortress) is under NTI (Narrow Therapeutic Index)? Thanks & Regards Anu |
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Helmut ★★★   Vienna, Austria, 2013-10-03 16:07 (4241 d 07:30 ago) @ Anu Posting: # 11599 Views: 5,098 |
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Hi Anu, ❝ Is Everolimus 0.75 mg (Zortress) is under NTI (Narrow Therapeutic Index)? See this post for APIs currently considered NTIDs in different regions. Since everolimus is a derivative of sirolimus I would ask the respective agency about their current thinking. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Anu ★ India, 2013-10-04 08:22 (4240 d 15:15 ago) @ Helmut Posting: # 11609 Views: 5,003 |
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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 |
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Helmut ★★★ Vienna, Austria, 2013-10-04 18:03 (4240 d 05:34 ago) @ Anu Posting: # 11612 Views: 4,917 |
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Hi Anu, ❝ […] 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. EMA does not (and does not intent to) publish a list of NTIDs. The Q&A summarizes the outcome of referral procedures (i.e., applicants and member states’ regulators disagreed and requested a decision by EMA’s CHMP). If a drug is not listed in the Q&A it only means that no study went through a referral so far. In other words, if all applicants and European regulators agree that a drug has a NTI, you will never find the drug mentioned in the Q&A.* ❝ 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. Personally I would follow the PK working party’s recommendations for tacrolimus (90.00–111.11% for AUC and 80.00–125.00% for Cmax). If in doubt seek scientific advice, as already suggested.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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drgunasakaran1 ★★  2013-10-03 18:09 (4241 d 05:28 ago) @ Anu Posting: # 11602 Views: 5,009 |
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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. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz