MR vs. Russian experts [Design Issues]
Hi BE-proff,
What do you mean?
EMA MR GL states:
The aim of the modified release formulation is therefore, in most cases, to reach a similar total exposure (AUC) to active substanceas for the immediate release formulation. This does not necessitate that the same nominal doses are given (the modified release formulation may have a different extent of absorptionor metabolism). In general modified-release formulations are not bioequivalent to their immediate release form. Consequently PK data alone may not be sufficient for evaluatingwhether the benefit/risk ratio of the modified release formulation is comparable to the corresponding doses of the immediate release form.
Yes, you can demonstrate the bioequivalence between MR and IR in SS. BTW do you really think that one study in steady state is sufficient to prove the rationale of development of new MR formulation?
Just follow the EMA MR GL, I think they will be satisfied
❝ I heard about cases when single-dose study didn't demonstrate BE between modified and immediate forms.
What do you mean?
EMA MR GL states:
The aim of the modified release formulation is therefore, in most cases, to reach a similar total exposure (AUC) to active substanceas for the immediate release formulation. This does not necessitate that the same nominal doses are given (the modified release formulation may have a different extent of absorptionor metabolism). In general modified-release formulations are not bioequivalent to their immediate release form. Consequently PK data alone may not be sufficient for evaluatingwhether the benefit/risk ratio of the modified release formulation is comparable to the corresponding doses of the immediate release form.
❝ In this case multi-dose regime would have smoothed curves and chances would have been higher
Yes, you can demonstrate the bioequivalence between MR and IR in SS. BTW do you really think that one study in steady state is sufficient to prove the rationale of development of new MR formulation?

❝ But how to explain it to experts?
Just follow the EMA MR GL, I think they will be satisfied

—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- BE study: modified vs immediate release BE-proff 2015-07-28 19:15 [Design Issues]
- BE study: modified vs immediate release Helmut 2015-07-29 13:06
- BE study: modified vs immediate release BE-proff 2015-07-30 08:27
- MR = twilight zone in Russia mittyri 2015-07-29 21:49
- MR = twilight zone in Russia BE-proff 2015-07-30 08:10
- MR vs. Russian experts mittyri 2015-07-30 11:04
- MR vs. Russian experts BE-proff 2015-07-30 11:46
- MR vs. Russian expertsmittyri 2015-07-30 15:23
- MR vs. Russian experts BE-proff 2015-07-30 11:46
- MR vs. Russian experts mittyri 2015-07-30 11:04
- MR = twilight zone in Russia BE-proff 2015-07-30 08:10
- BE study: modified vs immediate release Helmut 2015-07-29 13:06