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Helmut ★★★   Vienna, Austria, 2012-10-02 01:50 (4644 d 07:12 ago) Posting: # 9295 Views: 6,323 |
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Hi all (& especially John), FDA issued another guidance requiring partial AUCs for biphasic products (mixed salts of amphetamine, RLD Adderall XR). PK metrics are Cmax, AUC0-5, AUC5-t, AUC∞. Clinical justification of the truncation time point is similar to methylphenidate (tmax after IR 3±1h); but identical for fasting and fed studies (MPH: 3h fasting, 4h fed). — 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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jag009 ★★★ NJ, 2012-10-02 17:10 (4643 d 15:51 ago) @ Helmut Posting: # 9298 Views: 5,096 |
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Thanks Helmut. Do you know when the paper will be out? Not on FDA website yet, probably soon. John |
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Helmut ★★★ Vienna, Austria, 2012-10-02 17:32 (4643 d 15:30 ago) @ jag009 Posting: # 9299 Views: 4,978 |
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Hi John! ❝ Do you know when the paper will be out? It was already published last month. I suggest to follow the link in my post above.  In the future see here and top of this page.— 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, 2012-10-02 18:44 (4643 d 14:17 ago) @ Helmut Posting: # 9300 Views: 4,916 |
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Sorry  The arrows are in grey color, missed them.Edit:  ? I know, I know: The credo of designers should be “Form follows function.” [Helmut] |
Ing. Helmut Schütz