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RegisterBio-studies required for Carvedilol phosphate CR capsules [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2010-01-07 14:38 (6017 d 04:17 ago) – Posting: # 4572
Views: 2,821
Dear Madhava!
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.
❝ [...] 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.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Bio-studies required for Carvedilol phosphate CR capsules madhavaraob 2010-01-07 08:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bio-studies required for Carvedilol phosphate CR capsulesHelmut 2010-01-07 13:38
- Bio-studies required for Carvedilol phosphate CR capsules kiranActimus 2010-01-12 16:04
Ing. Helmut Schütz