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luvblooms ★★ India, 2011-05-11 16:34 (5530 d 08:50 ago) Posting: # 7012 Views: 4,140 |
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Dear Members greetings!! It would be nice if someone can suggest me a method to evaluate the BE of 5 mg Temozolamide capsules. Temozolamide is available in following strengths 5, 20, 100, 140, 180 and 250 mg. In our case our 20-250 mg are dose proportional and 5 mg is look alike to 100 mg. So for ANIVSA filing we have to do a BE for 5 mg strength as well along with 250 mg. But since the prescribed dose is 250 mg/ day for the patients and with 20 mg dosage patient is required to take 11-15 capsules/day. So higher number of capsules need to be taken in case of 5 mg dosage. Is there any other way to do this BE study. Luv — ~A happy Soul~ |
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Dr_Dan ★★ Germany, 2011-05-11 17:37 (5530 d 07:47 ago) @ luvblooms Posting: # 7013 Views: 3,350 |
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Dear Luv 50 capsules a 5 mg ⇒ fed study?  I discussed the possibility of performing a BCS class 1 biowaiver (avoiding any in vivo study at all) but ANVISA rejected this due to the fact that biowaivers are not reflected in their guidelines. Try to make the 5 mg dose proportional to the other strengths. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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luvblooms ★★ India, 2011-06-01 11:15 (5509 d 14:09 ago) @ Dr_Dan Posting: # 7044 Views: 3,262 |
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Dear Dr. Dan ❝ 50 capsules a 5 mg ⇒ fed study? Even we tried to explain the same thing to ANVISA but they do not want to buzz!!! ❝ Try to make the 5 mg dose proportional to the other strengths. That has been quite a difficult task for my formulation scientist but we still are working on that. Thanks Luv — ~A happy Soul~ |
Ing. Helmut Schütz