Bioequivalence and Bioavailability Forum

Dear all,

we know that the FDA uses internally, e.g., in all simulations which lead to its reference-scaling method for NTIDs.

THX to ElMaestro discovering another example. Though I attended the 4^th GBHI workshop last month in Bethesda, it is hidden in the backup slides.*

Of note, Robert Lionberger (Director Office of Research and Standards, Office of Generic Drugs) told me that he visits the Forum regularly. 

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• Liang Zhao (Division of Quantitative Methods and Modeling, ORS, OGD, CDER/FDA). FEV1 Based Bioequivalence Study for Inhaled Corticosteroids.