In generic development, we often try to save time by skipping steps. But skipping a pilot bioequivalence (BE) study is not always a good idea.
There are situations where going directly to the pivotal study can be risky. For example, if the drug is highly variable, poorly soluble, or has a narrow therapeutic index, the chances of failure are higher.
The same applies to modified release products or when the formulation is not very similar to the reference.
In these cases, in vivo performance is not easy to predict. A pilot BE study helps us understand the behavior of the formulation early.
It gives a chance to optimize before moving to the pivotal study, which ultimately saves time and cost.
So, the decision should not be based only on timelines.
It should come from proper scientific understanding and experience. In many cases, a pilot study is not an extra step.
Read also: Pilot BE Study of Pharmaceuticals
Read also: Vijay Agrawal