Bioequivalence and Bioavailability Forum

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

posted by nobody – 2017-07-25 11:30 (3256 d 19:57 ago) – Posting: # 17607
Views: 11,624

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

...any example?

❝ For Biowaiver: you need to document Highly soluble over the specified pH range and rapidly dissolving as deined under BCS class III (85% by 15 mins) and the biggest challenge you run into is in documenting reliable report on permeability If you can find a ADME paper documenting it is more than 80% bioavailable then that might work.

...totally clear, just wanted to see an example that worked in the end. Could not find one yet.

❝ Phenotype is not advisable in generic arena (IMHO) as we want to document that this drug is BE in general populating (meaning any breathing soul)....

EMA allows. See Jun 2017 by Laszlos and H- Blume on "real life" vs. "highly discriminative" in BE study requirements in various regions. Spoiler: Very inconsistent, in general...

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Edit: Reference added. [Helmut]
Endrényi L, Blume HH, Tóthfalusi L. The Two Main Goals of Bioequivalence Studies. AAPS J. 2017;19(4):885-90. doi:10.1208/s12248-017-0048-x

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