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Mohammed Ali ☆ United Arab Emirates, 2013-04-22 10:38 (4817 d 01:07 ago) Posting: # 10450 Views: 6,001 |
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Dear All , we are planning to do bioequivalence study on Azithromycin Caps, but whether we can use this methodology 2 capsule of 250mg of test & 2 caps of 250 mg of originator which will be equivalent to 500mg. please suggest whether this is accepted or not (pl. provide reference guidelines) Mohd. Ali |
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Helmut ★★★   Vienna, Austria, 2013-04-22 15:30 (4816 d 20:15 ago) @ Mohammed Ali Posting: # 10456 Views: 4,838 |
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Hi Mohammed, you replied to two posts (which were completely unrelated to your question). I deleted the first of your posts and made the second one the start of a new thread. See also the Forum’s Policy. ❝ we are planning to do bioequivalence study on Azithromycin Caps, ❝ but whether we can use this methodology 2 capsule of 250mg of test & 2 caps of 250 mg of originator which will be equivalent to 500mg. Why do you want to do that? Do you want to market only the 250 mg strength? If yes, perform a study with 1×1 250 mg. Only in rare cases (problems with the sensitivity of the analytical method) your design would makes sense. I don’t think any regulator would accept such a justification for azithromycin. ❝ […] pl. provide reference guidelines My crystal ball is at the laundry. In which country do you want to submit the study? — 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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Mohammed Ali ☆ United Arab Emirates, 2013-04-28 10:22 (4811 d 01:24 ago) (edited on 2013-04-28 11:38) @ Helmut Posting: # 10501 Views: 4,714 |
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❝ ❝ we are planning to do bioequivalence study on Azithromycin Caps, ❝ ❝ but whether we can use this methodology 2 capsule of 250mg of test & 2 caps of 250 mg of originator which will be equivalent to 500mg. We need 500mg Approval not 250mg whether this is acceptable as same study is been performed by Teva. ❝ Why do you want to do that? Do you want to market only the 250 mg strength? If yes, perform a study with 1×1 250 mg. Only in rare cases (problems with the sensitivity of the analytical method) your design would makes sense. I don’t think any regulator would accept such a justification for azithromycin. We need to market 500mg only. whether this is acceptable. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime] |
Ing. Helmut Schütz