Bioequivalence and Bioavailability Forum

Latest FDA product-specific guidelines – Some questions… [Regulatives / Guidelines]

posted by nobody – 2017-07-26 18:27 (2465 d 01:14 ago) – Posting: # 17617
Views: 9,860

❝ ❝ ❝ there are several drugs that doesn't require Fed BE study.

❝ ❝

❝ ❝ ...any example?

❝

❝ e.g Afatinib

OK, are there any systematics in "fast+fed" or "fasted only" decisions by the FDA guidances? Or is "fasted only" a new trend at the FDA?

❝ ❝ ...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

I know exactly what works out/would work out , all I'm looking for is are PARs with examples that actually made it to a biowaiver. Or the other way around: Has this ever worked with the FDA for generics?

Complete thread:

• Latest FDA product-specific guidelines – Some questions… nobody 2017-07-19 10:56 
  • 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
      • 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