Orodispersable tablets [Regulatives / Guidelines]
Hello drvahe,
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.
❝ 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
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
- Orodispersable tablets ElMaestro 2016-02-05 13:46
- Orodispersable tablets drvahe 2016-02-05 13:17
- 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
- BEQ Guideline in EAUnion Helmut 2016-02-16 14:06
- Orodispersable tabletsElMaestro 2016-02-05 12:33