Orodispersable tablets [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2016-02-05 13:33 (3298 d 20:35 ago) – Posting: # 15931
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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

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