Most in vitro ADME programs begin with a straightforward goal: generate the data needed to make the next development decision with confidence. The studies required to do that, however, can vary based on the compound, indication, development stage, available data, regulatory context, sponsor risk tolerance and the decision the team needs to make next.

A standard development checklist can provide a useful starting point, but the same set of studies will not fit every program. Effective in vitro ADME planning should therefore be fit for purpose. Rather than asking, “Which studies should we run?” development teams should start by asking: What are we trying to learn? What decision do we need to make next? What do we already know about the compound? What information is still missing? What are the risks of acting now, waiting, or moving forward without additional data?

A strong in vitro ADME strategy is not defined by how many studies are run. It is defined by whether the studies answer the questions that matter for the program. Learn more in this guide from BioIVT.