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Dr_Dan ★★ Germany, 2013-09-11 16:42 (4668 d 17:01 ago) Posting: # 11480 Views: 2,297 |
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Dear all For modified release products a multiple dose study is needed unless a single dose study has demonstrated that the mean AUC0-t after the first dose covers more than 90% (or 80%) of the mean AUCinf (no accumulation). If I have a combination product with an IR component and a MR component does the prerequisite for waiving the md study refers only to the MR component or do I have to show no accumulation also for the IR component? Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★   Vienna, Austria, 2013-09-11 16:51 (4668 d 16:52 ago) @ Dr_Dan Posting: # 11481 Views: 1,887 |
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Dear Dan, ❝ For modified release products a multiple dose study is needed unless a single dose study has demonstrated that the mean AUC0-t after the first dose covers more than 90% (or 80%) of the mean AUCinf (no accumulation). According to the draft GL! In the past we had endless discussions (+ deficieny letters) for a MR product showing only 0.7% accumulation (not kidding). I would not rely on the draft without backup by a “scientific” (actually regulatory) advice. ❝ If I have a combination product with an IR component and a MR component does the prerequisite for waiving the md study refers only to the MR component or do I have to show no accumulation also for the IR component? IMHO (!) components of a combo have to be assessed according the respective GLs. — 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