Bioequivalence and Bioavailability Forum

Hi Maggie,

Which guideline are you refering? EMA or FDA? Didn't find any product-specific guideline on ambroxol bioequivalence...

If you're refering to a more general guidance, FDA guideline for BE studies with pharmacokinetic endpoints states de following (section IV, D, 3):

For modified release products, we recommend the following studies: (1) a single-dose, fasting study comparing the highest strength of the test with the RLD, and (2) a single-dose fed BE study comparing the highest strength of the test with the RLD product. Because single-dose studies are considered more sensitive in addressing the primary question of BE (e.g., release of the drug substance from the drug product into the systemic circulation), multiple-dose studies are generally not recommended