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RegisterLatest FDA product-specific guidelines – Some questions… [Regulatives / Guidelines]
❝ ❝ there are several drugs that doesn't require Fed BE study.
❝
❝ ...any example?
e.g Afatinib
❝ ...totally clear, just wanted to see an example that worked in the end. Could not find one yet.
Floxacins, Solifenacin and there are few drugs with 100% bioavailability. essentially you demonstrate <10% fecal elimination of parent drug and more than 80% absoreption (drug and metabolite combined) or >90% renal elimination of parent drug, with data or permability study data it should work out
Edit: quotes corrected [Ohlbe]
Complete thread:
- Latest FDA product-specific guidelines – Some questions… nobody 2017-07-19 10:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Latest FDA product-specific guidelines – Some questions… jag009 2017-07-20 05:12
- Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-24 23:23
- Latest FDA product-specific guidelines – Some questions… nobody 2017-07-25 09:30
- Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-25 17:33
- Standardisation of the population Ohlbe 2017-07-25 18:41
- Standardisation of the population Helmut 2017-07-25 19:35
- Standardisation of the population Ohlbe 2017-07-25 18:41
- Latest FDA product-specific guidelines – Some questions…Achievwin 2017-07-25 18:21
- Latest FDA product-specific guidelines – Some questions… nobody 2017-07-26 16:27
- Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-25 17:33
- Latest FDA product-specific guidelines – Some questions… nobody 2017-07-25 09:30
Ing. Helmut Schütz