Bioequivalence and Bioavailability Forum

increased solubility = different PK profile? [Dissolution / BCS / IVIVC]

posted by nobody – 2017-06-08 19:16 (3296 d 19:36 ago) – Posting: # 17462
Views: 17,452

Hi Dr!

To me: That's not how it works with generics. Go for equivalent dissolution and therefore Cmax/AUC. End of story.

Why go for "better" solubility and end up non-BE? Don't see the point at all.

You could go for some hybrid application in Europe (regulatory is not my piece of cake), but good luck with explaining the "advantage" of your product to the authority(ies)

Complete thread:

• increased solubility = different PK profile? Dr_Dan 2017-06-08 16:57 
  • increased solubility = different PK profile?nobody 2017-06-08 17:16
  • increased solubility = different PK profile? Helmut 2017-06-08 17:18
    • increased solubility = different PK profile? nobody 2017-06-08 17:22
      • ka vs. Cmax Helmut 2017-06-09 14:35
        • ka vs. Cmax nobody 2017-06-09 16:27
        • ka vs. Cmax mittyri 2017-06-10 14:59
  • increased solubility = different PK profile? ElMaestro 2017-06-08 17:24
    • increased solubility = different PK profile? Dr_Dan 2017-06-08 17:36
      • increased solubility = different PK profile? nobody 2017-06-08 17:43
      • increased solubility = different PK profile? Ohlbe 2017-06-08 18:23
        • increased solubility = different PK profile? nobody 2017-06-08 18:58
      • increased solubility = different PK profile? ElMaestro 2017-06-08 18:45
        • increased solubility = different PK profile? nobody 2017-06-08 18:57
          • increased solubility = different PK profile? nobody 2017-06-09 09:38
  • increased solubility = different PK profile? Kiran 2017-06-24 11:02