MaggieSantos ☆ Portugal, 2016-10-28 20:16 (2707 d 20:00 ago) Posting: # 16755 Views: 3,329 |
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Dear colleagues, I have been asked to perform a bioequivalence study on ambroxol, sustained release formulations containing 75 mg. according to guideline a single dose fast study as well as a single dose fed may be applicable. The multiple dose study is also required due to accumulation, according to ambroxol half-life between 7 and 12 hours. I would like to have inputs from experienced researchers in order to aware of any concerns related to this substance. Kind Regards |
DavidManteigas ★ Portugal, 2016-11-02 11:51 (2703 d 03:25 ago) @ MaggieSantos Posting: # 16764 Views: 2,619 |
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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 |