Isotechnika Pharma Inc IPHAF

RE: Filed: July 13, 2005

[labumba]

"I think your missing the point I do believe they have the dosing right for renal it’s the psoriasis that’s the contention." I don't think I missed your point. What I said is they could have also used the pk/pd data from Renal2A and Psoriasis2 trial to support their summary in this abstract theoretically. Seeing this abstract was filed in July 05, the pk/pd data of both above had definitely been used.( at this point I haven't read the abstract yet ). What I am saying the trans247 have wider therapuetic window than mix. That means the space gap between the Cmax ( peak maximum )level and Cmin ( trough minimum )is wider and therefore, there is more " time room " to adjust the dosage by stressing out the time between dosing. The AUC is alterd in the process but the efficacy value is still maintained with less susceptable to toxicity. Back to your belief that their dosing were wrong in psoriasis 3 trial . If you are using that two pharmacokinetic analysis study models as mentioned to back up your statement, you could be wrong. Why ? How did you know what model they were adopting for adjusting the dosing time in psoriasis ph3 ? For example, take 0.4 mg twice daily = 0.8 mg on 24 hours regimen and every individual has his/her pharacokinetic average, how did you find out they didn't emphasize their dosing on peak concentration or on low end trough ( minimum concentration) level by adjusting the time between the doses in Psoriasis 3 trial. By the way, they have their new invention /method available to find out the pharmacokinetic average of each patient.