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ioanam ★ Romania, 2007-03-18 01:27 (7032 d 22:32 ago) Posting: # 584 Views: 5,077 |
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Dear Sir, I have to perform a bioequivalence study with two strengths (120 mg and 160 mg) for a modified release formulation, which are not dose proportional. The Orange book specifies only 160 mg formulation as RLD. There is also an innovator for 120 mg, but it is not listed as RLD. In that case what shall be the reference drug for 120mg strength? Thank you. |
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Helmut ★★★   Vienna, Austria, 2007-03-18 14:21 (7032 d 09:38 ago) @ ioanam Posting: # 585 Views: 3,976 |
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Dear ioanam! Since your drug is not dose proportional, and I don't expect it will be an realistic option to administer the lowest common multiple (480mg) of test (4×120mg) and RLD (3×160mg), IMHO it would make sense to go for a comparative BA with the other innovator's 120mg formulation. Such a procedure is not BE in FDA's sense (reference not the RLD); you must contact CDER/OGD's review staff first! — 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