Bioequivalence and Bioavailability Forum • Orodispersable tablets

Orodispersable tablets [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2016-02-05 13:33 (3437 d 14:31 ago) – Posting: # 15931
Views: 5,644

Hello drvahe,

❝ Could you please give me advise about orodispersable tablets (ODS)? May an in vivo bioequivalence study demonstrate the bioequivalence of ODT to a film-coated tablet? Could you indicate me a guideline regulating this aspect?

EMA's BE guideline from 2010, section 1.2:
"(...) the various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form."

Have a good weekend.

—
Pass or fail!
ElMaestro

Complete thread:

Orodispersable tablets drvahe 2016-02-05 09:41 [Regulatives / Guidelines]
- Orodispersable tabletsElMaestro 2016-02-05 12:33
  - Orodispersable tablets drvahe 2016-02-05 13:17
    - Orodispersable tablets ElMaestro 2016-02-05 13:46
      - Orodispersable tablets drvahe 2016-03-10 11:56
- BEQ Guideline in EAUnion mittyri 2016-02-16 00:08
  - BEQ Guideline in EAUnion Helmut 2016-02-16 14:06
    - BEQ Guideline in EAUnion mittyri 2016-02-16 21:40
  - BEQ Guideline in EAUnion drvahe 2016-02-23 09:03