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Ravi ★ India, 2010-05-18 08:52 (5881 d 04:02 ago) Posting: # 5340 Views: 7,896 |
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Dear All, I am a bit confussed about dose linearity. My question is Suppose for a drug dose linearity is established with in the range of 3 to 10mg. Then What can we say about the 2mg dose of the same drug. Whether we can consider dose linearity at 2mg dose also or not. — Thanks & Regards Ravi Pandey |
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Helmut ★★★   Vienna, Austria, 2010-05-18 10:23 (5881 d 02:31 ago) @ Ravi Posting: # 5343 Views: 6,459 |
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Dear Ravi! ❝ [...] dose linearity is established with in the range of 3 to 10mg. ❝ [...] can we consider dose linearity at 2mg dose also or not. What do you mean by "consider"? It is likely that 2mg will be also in the linear range - but it has not been demonstrated yet. — 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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ElMaestro ★★★ Denmark, 2010-05-18 11:00 (5881 d 01:54 ago) @ Ravi Posting: # 5344 Views: 6,442 |
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Hi Ravi, I agree with HS, but you may have an ace up your sleeve still: There is one point on the curve that is known much better than any other point, and thats the one corresponding to a zero dose when Cmax or AUC is zero (we not talking endogenous compounds, right?). So if your curve for linearity, when extraploted backwards, goes through (0,0) with overwhelming certainty*, then you have a rather strong argument for linearity in the region 0 - 3 which I guess is what you need. It may well be accepted by regulators. Best regards EM. *: No principles here. Fight for it with your own arguments. |
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Ravi ★ India, 2010-05-18 13:24 (5880 d 23:30 ago) @ ElMaestro Posting: # 5346 Views: 6,428 |
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Dear HS and Elmestro, Thanks for your quick response. — Thanks & Regards Ravi Pandey |
Ing. Helmut Schütz