Are all batches of drug equal or are some more equal than others?

In standard bioequivalence assessment, typically the pharmacokinetic characteristics of a single batch of a reference product is compared to a revised formulation or a new generic version. However, an often overlooked issue is that of batch-to-batch variability of reference, which can seriously impact the power and consumer risk associated with a regular 2 period crossover design especially when the reference drug is bioinequivalent to itself. This issue has recently been investigated with some interesting results and possible implications for bioequivalence regulatory guidelines. Click here to read the latest publication.