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Hi there,
Could someone please help me with this. Do we get Bioequivalence Recommendations for Specific Products on EMA site, the way they are available on FDA site. (http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm)
My requirement is, per FDA recommendations for Spironolactone, analytes to be measured for showing BE is just the parent compound. But as we are planning for MHRA submission, I am not sure if MHRA insists on metabolites as well.
Literature shows that, Spironolactone is extensively metabolized; it has three known active metabolites: canrenone, 7-thiomethylspironolactone, and 6-hydroxy-7-thiomethylspironolactone.
Your advise on this will be highly appreciated.
Kind regards
CR
Could someone please help me with this. Do we get Bioequivalence Recommendations for Specific Products on EMA site, the way they are available on FDA site. (http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm)
My requirement is, per FDA recommendations for Spironolactone, analytes to be measured for showing BE is just the parent compound. But as we are planning for MHRA submission, I am not sure if MHRA insists on metabolites as well.
Literature shows that, Spironolactone is extensively metabolized; it has three known active metabolites: canrenone, 7-thiomethylspironolactone, and 6-hydroxy-7-thiomethylspironolactone.
Your advise on this will be highly appreciated.
Kind regards
CR
Complete thread:
- Bioequivalence Recommendations for Specific Productscr.maroj 2013-09-19 11:00 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence Recommendations for Specific Products Ohlbe 2013-09-19 11:45
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- EMA: Draft product-specific guidances ♬ Helmut 2013-11-15 15:45
- EMA: generally no product-specific GLs Helmut 2013-09-19 11:48
- Thank you cr.maroj 2013-09-19 13:03
- EMA: generally no product-specific GLs The Outlaw Torn 2013-09-20 07:52
- EMA: parent whenever possible Helmut 2013-09-20 09:02
- EMA: parent whenever possible cr.maroj 2013-09-20 10:14
- EMA: parent whenever possible Helmut 2013-09-20 12:53
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- EMA vs. Russia Helmut 2013-09-20 19:21
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- FDA: Prasugrel Helmut 2013-12-20 13:46
- FDA: Prasugrel intuitivepharma 2013-12-24 06:38
- FDA: Alternative approaches… Helmut 2013-12-24 14:15
- FDA: Alternative approaches… intuitivepharma 2013-12-26 05:11
- FDA: RTR Helmut 2013-12-26 14:35
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- WayBack Machine Helmut 2015-07-23 16:58
- FDA: RTR Helmut 2013-12-26 14:35
- FDA: Alternative approaches… intuitivepharma 2013-12-26 05:11
- FDA: Alternative approaches… Helmut 2013-12-24 14:15
- FDA: Prasugrel intuitivepharma 2013-12-24 06:38
- FDA: Prasugrel Helmut 2013-12-20 13:46
- FDA: Prasugrel intuitivepharma 2013-12-20 07:36
- EMA: parent whenever possible ElMaestro 2013-09-20 19:35
- EMA: Sirolimus product-specific GL luvblooms 2013-11-19 13:00
- EMA vs. Russia Helmut 2013-09-20 19:21
- EMA: parent whenever possible mittyri 2013-09-20 14:55
- EMA: parent whenever possible Ohlbe 2013-09-20 13:52
- EMA: parent whenever possible Helmut 2013-09-20 12:53
- EMA: parent whenever possible cr.maroj 2013-09-20 10:14
- EMA: parent whenever possible Helmut 2013-09-20 09:02
- Bioequivalence Recommendations for Specific Products Ohlbe 2013-09-19 11:45
Ing. Helmut Schütz