looking at those two formulations, whether it be the same manufacturer making changes in their formulation, whether it's questions between whether two lots are indeed far enough away to cause clinical problems or whether it's looking at a generic product or a substitutable product from another manufacturer.
The question is always back to how have they made that formulation, how successful have they been in controlling both the variability in the performance of the formulation, as well as whether that formulation hits its target or the performance characteristics that that manufacturer, the formulation designer is going for. So we generally look at the performance in basic as the release of the drug substance from the drug product.
As I said before, I think we can all agree the drug substance has to get out of the drug product to be able to get into the body and create a therapeutic effect, and based on regulations of what we're instructed to do and on good science, we're looking at both the extent of release or the extent of availability from any formulation as well as how quickly it happens or the rate.
We saw a couple of examples where baseline