Bioequivalence and Bioavailability Forum • Locally applied drugs

Locally applied drugs [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2015-03-02 15:42 (4139 d 07:01 ago) – Posting: # 14528
Views: 6,556

Hi nobody,

❝ Are there any EPARs or stuff like that out there on positive examples?

❝ Any details (publicly ;-) ) available on the class of compounds involved?

None that I know of. These things tend to fail.

❝ Definitely an approach to be confirmed by a well-prepared Sci Adv, I guess :-)

Yes and also a technical evaluation. It is all about the LLOQ. An agonising choice: Do you wish to do the technical feasibility first (perhaps even not knowing the absorption / prospective plasma levels) or do you want the sc. advice first? It's going to cost $$$ before you get started.

—
Pass or fail!
ElMaestro

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 drugsElMaestro 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 drugs nobody 2015-03-02 16:31