Bioequivalence and Bioavailability Forum

Locally applied drugs [Regulatives / Guidelines]

posted by nobody – 2015-03-02 17:31 (4132 d 20:39 ago) – Posting: # 14532
Views: 6,531

❝ ....Otherwise in case of deep penetration the drug substance would become systemically available, right?

Maybe, but what you are looking for are differences between formulations, e.g. if your new formulation results in higher systemic availability than the originator, which might result in safety issues. Would be hard to determine from the skin data (IIRC there are some Scotch-tape "stripping" models, too, on dermal penetration, resulting in a little more resolution of penetration depth).

A combination with systemic data (ala Maestro) appears mandatory to me, at least in most cases. But maybe I'm even more conservative than Europ. regulators?

Complete thread:

• Locally applied drugs Melkor 2015-03-02 12:22 
  • Locally applied drugs nobody 2015-03-02 12:27
    • Locally applied drugs Melkor 2015-03-02 12:43
      • Locally applied drugs ElMaestro 2015-03-02 12:48
        • Locally applied drugs nobody 2015-03-02 14:32
          • Locally applied drugs ElMaestro 2015-03-02 14:42
          • Locally applied drugs ioanam 2015-03-19 14:44
            • Locally applied drugs nobody 2015-03-19 15:20
  • Locally applied drugs Dr_Dan 2015-03-02 15:56
    • Locally applied drugs nobody 2015-03-02 16:01
      • Locally applied drugs Dr_Dan 2015-03-02 16:22
        • Locally applied drugsnobody 2015-03-02 16:31