Ambroxol Sustained Release 75 mg [Design Issues]
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
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
Complete thread:
- Ambroxol Sustained Release 75 mg MaggieSantos 2016-10-28 18:16 [Design Issues]
- Ambroxol Sustained Release 75 mgDavidManteigas 2016-11-02 10:51