Abstract
In 2013, the US FDA published a draft guidance document for the development of generic dry powder inhalers containing fluticasone propionate and salmeterol xinafoate. This article discusses the requirements of the FDA’s draft guidance and makes comparison to the general requirements of the EU. Getting US regulatory approval for a generic dry powder inhaler containing fluticasone propionate and salmeterol xinafoate will be very difficult due to the testing burden if the requirements given by the draft guidance are all implemented. It will involve a total of 50 tests (36 in vitro, 12 pharmacokinetic, 2 pharmacodynamic), which must all evaluate towards equivalence. This means each of the 50 individual tests must be highly powered in order to get an acceptable level of overall success. An ethical concern over the use of pivotal in vivo trials on the basis of in vitro data only is raised.
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