Bioequivalence Testing for
Locally Acting Gastrointestinal Drugs
For locally acting GI drugs, is PK, if measurable, an
test sensitive to formulation performance and useful as a
part of a determination of bioequivalence?
Are there any drug specific issues that would aid FDA in
interpreting the results of a PK study on a GI acting drug
with respect to a conclusion about bioequivalence?
When is it possible to use dissolution testing alone to
demonstrate bioequivalence of GI acting drugs?
When should comparative clinical trial studies be
conducted to demonstrate bioequivalence?