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mittyri ★★ Russia, 2014-06-10 22:05 (4402 d 06:53 ago) Posting: # 13053 Views: 3,411 |
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Dear All, According to the EU GL AUC truncated at 72 h (AUC(0-72h)) may be used as an alternative to AUC(0-t) for comparison of extent of exposure as the absorption phase has been covered by 72 h for immediate release formulations. Do we need to put in the Protocol any justification about "the absorption phase has been covered by 72 h"? Could you help with Absorption Phase calculation from literature data? I've found only a simple method AP<2-4×tmax (from Helmut's Lecture  )— Kind regards, Mittyri |
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Helmut ★★★   Vienna, Austria, 2014-06-10 23:17 (4402 d 05:42 ago) @ mittyri Posting: # 13054 Views: 2,751 |
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Hi Mittyri ❝ Do we need to put in the Protocol any justification about "the absorption phase has been covered by 72 h"? As long as you are dealing with IR, no. There is a consensus (based on numerous studies on transfer times by scintigraphy, magnetic marker imaging,  ) that no API can stay longer than ~three days in the GIT. That sets a natural end to absorption, right?❝ Could you help with Absorption Phase calculation from literature data? I've found only a simple method ❝ AP<2-4×tmax Yep, that’s strictly only valid for the one compartment model. You could play around with Wagner-Nelson (one compartment) or Loo-Riegelman (two compartments) as well. But as said above, it is not necessary. — 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 |
Ing. Helmut Schütz