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cakhatri ★ India, 2013-03-12 17:44 (4858 d 06:34 ago) Posting: # 10192 Views: 5,155 |
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Dear Members, For IR products, guidelines have provision to truncate AUC at 72 hrs. Is anyone aware of the guidelines for truncation of AUC at 72 hrs for modified release products having longer half life. Regards Chirag |
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Helmut ★★★   Vienna, Austria, 2013-03-12 17:57 (4858 d 06:22 ago) @ cakhatri Posting: # 10193 Views: 4,468 |
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❝ Is anyone aware of the guidelines for truncation of AUC at 72 hrs for modified release products having longer half life. I don’t know any. If IR is concerned long half life is irrelevant for truncation (see EMA’s GL); it’s high time for the FDA to revise their guidance.  The 72 hours are based on the longest passage time of a formulation in the GIT.If the MR formulation is DR IMHO truncation should be applicable as well. For CR you might observed flip-flop PK – terminal phase represents absorption or is at least influenced by it. Personally I would be very wary to even use AUCt as the main metric. I would rather use AUC∞ and aim for an extrapolated area of well below 20%. — 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, 2013-03-12 21:24 (4858 d 02:55 ago) @ Helmut Posting: # 10196 Views: 4,344 |
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Dear Chirag! ❝ ❝ Is anyone aware of the guidelines for truncation of AUC at 72 hrs for modified release products having longer half life. ❝ ❝ I don’t know any. If IR is concerned long half life is irrelevant for truncation (see EMA’s GL); it’s high time for the FDA to revise their guidance. ❝ If the MR formulation is DR IMHO truncation should be applicable as well. ❝ For CR you might observed flip-flop PK – terminal phase represents absorption or is at least influenced by it. Personally I would be very wary to even use AUCt as the main metric. I would rather use AUC∞ and aim for an extrapolated area of well below 20%. I don't recall running ANDA BE studies. However when I conducted BA (relative bio) studies comparing two ER products (its was for a 505(b)2 submission, to demonstrate bioequivalence between 2 product of same active but in different salt form), the pk profile timepoints were set based on the half-life of the drug (t1/2 was something like 16-20 hrs)... John |
Ing. Helmut Schütz