Questions – Bioequivalence Testing for Locally Acting Gastrointestinal Drugs
1.For locally acting GI drugs, is PK, if measurable, an in vivo test sensitive to formulation performance and useful as a part of a determination of bioequivalence?
2.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?
3.When is it possible to use dissolution testing alone to demonstrate bioequivalence of GI acting drugs?
4.When should comparative clinical trial studies be conducted to demonstrate bioequivalence?
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