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madhavaraob ☆ 2010-01-07 09:25 (6019 d 06:14 ago) Posting: # 4568 Views: 3,240 |
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Dear All, Please suggest, what are the BE studies required for Carvedilol phosphate CR capsules for USFDA submission and also on which strengths it need to conduct studies. For your information this drug is available as 10, 20, 40, 80 mg capsule formulations. With Regards, Madhava Rao |
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Helmut ★★★   Vienna, Austria, 2010-01-07 14:38 (6019 d 01:01 ago) @ madhavaraob Posting: # 4572 Views: 2,834 |
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Dear Madhava! ❝ [...] what are the BE studies required for Carvedilol phosphate CR capsules ❝ for USFDA submission and also on which strengths it need to conduct studies. ❝ For your information this drug is available as 10, 20, 40, 80 mg capsule ❝ formulations. FDA's Guidance gives some preliminary information (2 studies: single dose fasting/fed; parent+metabolite). This information applies to the IR tablet. None of the extended release capsules are RLDs. I would suggest contacting FDA's review staff. — 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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kiranActimus ☆ India, 2010-01-12 17:04 (6013 d 22:35 ago) @ madhavaraob Posting: # 4587 Views: 2,720 |
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Dear Madhava We have done BE Studies of Carvedilol Phosphate 80mg CR capsules in fasing, fed and fasting sprinkle conditions and i would suggest you the same as we go for BE studies on the highest strength available in the market. More views welcome from the experts Regards KK |
Ing. Helmut Schütz