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dhavalpanchal ☆ India, 2010-04-12 13:37 (5918 d 04:41 ago) Posting: # 5085 Views: 4,111 |
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Dear Members, We are working on a molecule which shows high intrasubject variability (around 85% for Cmax) and having Narrow Therapeutic Index. What can be the ideal study design to establish bioequivalence on the same ? regards, Dhaval |
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ElMaestro ★★★ Denmark, 2010-04-12 14:55 (5918 d 03:22 ago) @ dhavalpanchal Posting: # 5086 Views: 3,279 |
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Hi dhavalpanchal, ❝ We are working on a molecule which shows high intrasubject variability (around 85% for Cmax) and having Narrow Therapeutic Index. To a not small proportion of people working in this field (on both sidses of the fence, I think) NTI and HVD are often mutually exclusive terms. I'd recommend you to get central scientific advice. It could come down to a lot of specifics. Best regards EM. Addendum: See e.g. here. An EU regulator discussing NTI drugs that "If they were HVD/P, they could not be used since a very similar drug levels are necessary between administrations". — Pass or fail! ElMaestro |
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Helmut ★★★   Vienna, Austria, 2010-04-12 17:08 (5918 d 01:10 ago) @ ElMaestro Posting: # 5092 Views: 3,327 |
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Dear ElMaestro, agree with your points. See also Suzanna’s slide 51: … it is likely that NTI drugs are not HVD (otherwise subjects would routinely experience lack of efficacy or toxicity due to the drug’s variability) I think Leslie Benet first made this statement at the BioInternational Conference 1994 in Munich. See also his presentation at FDA’s Advisory Committee for Pharmaceutical Science from 2004. @Dhaval: Out of curiosity – can you give your HV/NTI-drug a name? — 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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dhavalpanchal ☆ India, 2010-04-13 09:03 (5917 d 09:14 ago) @ Helmut Posting: # 5103 Views: 3,240 |
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❝ @Dhaval: Out of curiosity - can you give your HV/NTI-drug a name? Dear HS, Yes, its Mycophenolic Acid DR tablet |
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jayeshd ● 2010-04-17 12:16 (5913 d 06:01 ago) (edited on 2010-04-17 20:20) @ dhavalpanchal Posting: # 5160 Views: 3,227 |
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We are also working witn the same type of drug and we have used the scaled average bioequivalence approach (reference-replicated study). Around 60 subjects with a CV as high as 85% will provide at least an 85% probability of success. Thanks Jayesh Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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