Bioequivalence Testing during Drug Development

There is an expectation from the Regulatory Authorities that clear links can be established between the initial preclinical testing through continuing safety testing and early clinical studies to the final commercial product. Bioequivalence will be part of that linkage whenever there is a change in formulation. For example, very often the formulation used in early clinical studies is not suitable for final commercial use, and a switch is made at some point prior to final product approval.

The key linkage (or 'bridging') will be to demonstrate adequate bioequivalence between the initial clinical formulation and the final commercial formulation. If bioequivalence cannot be demonstrated, then clinical equivalence will need to be demonstrated; requiring more extensive, time-consuming and costly investigations.

FinnBrit Consulting has the necessary expertise to advise clients on how to effectively plan such changes.

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