Bioequivalence and Bioavailability Forum

Dear Helmut

❝ Are you talking about bioequivalence?

Is a Bioavailability study 3x6x3: FDC (NSAID active-enantiomer + Opioid racemate) vs (NSAID active-enantiomer or Opioid racemate)

❝ ❝ The enantiomers exhibit different pharmacodynamic characteristics but only the active enantiomer is going to be in the formulation.

❝ ❝ There is no in-vivo interconversion.

❝ ❝ The reference standard is going to be the enantiomer (not racemate).

❝ ❝ Is a chiral method required? Can I go with a simple achiral method?

❝

❝ Which regulation? F.i. the FDA’s requirements concerning chiral methods are diametral to the EMA’s (see also here and there). Can’t find anything in the Mexican one.

Neither do I, so State of the art regulation

❝ One of the prerequisites in BE is that same molar doses of the active ingredient are administered. If the enantiomeric ratio* of the reference is 1:1, IMHO, you would have to administer twice the dose of the test and use a chiral method (assessing only the active enantiomer for BE).

Thank you

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]