BE study: modified vs immediate release [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2015-07-29 15:06 (3480 d 19:13 ago) – Posting: # 15169
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Hi BE-proff,

❝ I have to demonstrate BE between modified release product (taken once a day) and immediate-release product (taken twice a day).


Think about (EMA’s) definition of bioequivalence:

Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.

Will not work (by definition).

❝ IMHO there is a risk that both product can show different kinetics and they won't be equivalent in 1-time administration of each medications.


Not a risk at all; different PK is the rationale for developing modified release formulations (better compliance due to fewer administrations, less fluctuations, etc.).

❝ To avoid this risk I think of steady state study.

❝ But how to prove my idea based on actual guides?


Was too lazy to check Russian requirements, but have a look at EMA’s GL, Section “Application for a modified release formulation of a drug that is authorised in a formulation with a different release rate” for details.

❝ Does anybody have such experience?


Yes. :-D
Single dose, generally multiple dose, food effect, dose proportionality, in vitro dose dumping (C2H5OH) + at least one clinical study. In the EU that’s called a “hybrid application”.

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