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Deep patel ☆ India, 2016-06-03 15:34 (3672 d 14:01 ago) Posting: # 16390 Views: 6,876 |
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Dear All, As per FDA's Bioequivalence recommendations for Ivermectin 3mg tablets, they recommended to conduct single dose, two-way crossover fasting study with 2 x 3 mg tablet (6 mg dose). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm296901.pdf We are planning to conduct bioequivalence study for Ivermectin 3mg tablets for EU. The product administration posology ranges from 1 tablets to 8 tablets depending upon body weight. Link to SmPC of one of the available generic product is given below for ready reference. http://db.cbg-meb.nl/IB-teksten/h117488_fsuk.pdf Please suggest which dose to be used in BE study for EU market (1 tablet of 3 mg or 2 tablets of 3 mg or any other dose). Thanks. Kind regards |
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Helmut ★★★   Vienna, Austria, 2016-06-03 17:09 (3672 d 12:26 ago) @ Deep patel Posting: # 16391 Views: 5,779 |
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Hi Deep, please see this post #3. Contrary to the FDA (generally requiring the highest dose) the EMA requires the most sensitive strength (for the conditions see the BE-GL Section 4.1.6). Since you want to apply only for one strength, a single dose study in fasting state (1 × 3 mg) is sufficient. — 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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Deep patel ☆ India, 2016-06-04 15:18 (3671 d 14:17 ago) @ Helmut Posting: # 16398 Views: 5,604 |
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Hello Helmut, Many thanks for your feedback. It is now clear to me. Kind regards, Deep Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Ing. Helmut Schütz