Bioequivalence and Bioavailability Forum

Locally applied drugs [Regulatives / Guidelines]

posted by Melkor – Greece, 2015-03-02 13:22 (4135 d 08:12 ago) – Posting: # 14522
Views: 7,565

Greetings,

I was wondering what are the exact requirements for a generic cream formulation concerning clinical data. According to EMA guidelines therapeutic equivalence is required to be demonstrated nevertheless; would a biowaiver for a locally non-systemic cream-lotion be acceptable in case relevant in vitro data is provided?

Thank you.

Complete thread:

• Locally applied drugsMelkor 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 drugs nobody 2015-03-02 16:31