An Alternative Pharmacokinetic Approach to Bioequivalence: Multibatch Experience with Flovent DPI
Sandell D, Wieczorek M.
Respiratory Drug Delivery 2018. Volume 1, 2018: 255-264.
Abstract:
The task to show bioequivalence (BE) in pharmacokinetic parameters between an orally inhaled drug product (OIP) generic candidate and the associated reference listed drug (RLD) has historically been very challenging. Recent published data has shown that one reason for this is the large variability that may be present between RLD batches. In such a situation it is evident that a randomly selected single batch cannot represent the product and thus, that innovative clinical test designs and revised regulatory guidance are required to remove this hurdle impeding the introduction of much needed generic inhalers.
A multiple-batch approach where the TEST product is compared to a mix of RLD batches has been suggested and shown to improve the chance of drawing the correct decision. The considerations associated with the planning of a pilot pharmacokinetic study comparing Flovent® Diskus® to a candidate generic is presented where the selected multiple batch design is justified.
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