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Rock ☆ India, 2019-10-16 15:38 (1883 d 23:22 ago) Posting: # 20691 Views: 5,917 |
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In a study comparing Test (Immediate Release) vs. Reference (Modified Release) formulations, on which formulations the withdrawal criteria on emesis should be based and why? Edit: Category changed; see also this post #1. Please follow the Forum’s Policy. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2019-10-16 15:53 (1883 d 23:07 ago) @ Rock Posting: # 20692 Views: 5,206 |
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Hi Rock, ❝ In a study comparing Test (Immediate Release) vs. Reference (Modified Release) formulations, on which formulations the withdrawal criteria on emesis should be based … For the IR formulation most people opt at two times the median tmax. For the MR formulation the entire intended dosing interval. ❝ … and why? IR: That’s the inflection point of the profile where absorption is essentially (98.44%) complete. MR: Since you likely are facing flip-flop PK (where the late part of the profile represents absorption). Hence, for o.a.d. 24 hours, for b.i.d. 12 hours (even if you administered it only once). — 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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nobody nothing 2019-10-16 17:22 (1883 d 21:38 ago) @ Helmut Posting: # 20694 Views: 5,160 |
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❝ MR: Since you likely are facing flip-flop PK (where the late part of the profile represents absorption). ...which is "very conservative", to say the least (and stay politicialy correct....) btw. since when do you load scripts from cloudf**k for the forum? Don't like... — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2019-10-16 19:24 (1883 d 19:36 ago) @ nobody Posting: # 20695 Views: 5,170 |
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Hi nobody, ❝ ❝ MR: Since you likely are facing flip-flop PK... ❝ ❝ ...which is "very conservative", to say the least (and stay politicialy correct....) As usual: Know the drug, know your formulation.  ❝ btw. since when do you load scripts from cloudf**k for the forum? Don't like... Since I implemented MathJax to render ![[image]](img/uploaded/image338.png) a couple of months ago. It was a wish of other members for years. That's the same open source script base which is used in R's documentation and Wikipaedia. I could keep a local copy on my server but then
![[image]](img/uploaded/image623.png) .— 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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nobody nothing 2019-10-16 20:41 (1883 d 18:19 ago) @ Helmut Posting: # 20696 Views: 5,162 |
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❝ ❝ btw. since when do you load scripts from cloudf**k for the forum? Don't like... ❝ ❝ Since I implemented MathJax to render
.OK, thanks for reply, script blocking remains ON, until absolutely necessary... — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2019-10-16 21:02 (1883 d 17:58 ago) @ nobody Posting: # 20697 Views: 5,161 |
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Hi nobody, ❝ OK, thanks for reply, script blocking remains ON, until absolutely necessary... Sure, why not? Try this one. There is one difference to the implementation in Wikipaedia. If JS is not active, WP serves GIFs with the -code in the alt-attribute of the <img> tag (for people who switched off graphis or rely on screen-readers). Would need a hell of coding here.— 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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mittyri ★★ Russia, 2019-10-17 02:01 (1883 d 12:59 ago) @ Helmut Posting: # 20698 Views: 5,200 |
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Hi Helmut, ❝ For the IR formulation most people opt at two times the median tmax. that's right, but in such case the PK scientist should know the median before the analysis starts, should he? Or to exclude the subject after PK analysis, when the median is calculated? Or should he use the published median Tmax? — Kind regards, Mittyri |
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Helmut ★★★ Vienna, Austria, 2019-10-17 10:42 (1883 d 04:18 ago) @ mittyri Posting: # 20699 Views: 5,112 |
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Hi mittyri, ❝ […] use the published median Tmax? Yep – should be given in the SmPC/label. The exclusion should be done by the PI (or a sub-investigator). Sometimes I find statements like “the decision will be done by the pharmacokineticist after discussion with the sponsor” in protocols. Fishy. — 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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jag009 ★★★ NJ, 2019-10-22 23:26 (1877 d 15:34 ago) @ mittyri Posting: # 20713 Views: 4,922 |
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Hi, ❝ that's right, but in such case the PK scientist should know the median before the analysis starts, should he? Or to exclude the subject after PK analysis, when the median is calculated? Or should he use the published median Tmax? You referring to reference? If so its usually stated in the protocol (usually). J |
Ing. Helmut Schütz