Expert Perspective: How Microdosing In Clinical Trials Is Accelerating Drug Development

Microdosing has traditionally been used as an early-phase clinical development tool, but developers are increasingly exploring whether the same drug-in-capsule approach can support a program through Phase 3 and into commercial supply.

In this Q&A, Jutta Wagner, Global Program Director, and Christian Rose, Manager of Process Engineering, two Thermo Fisher Scientific specialists based in Basel, Switzerland, share their perspectives on this evolving approach. They discuss how precision filling at doses ranging from 1 to 200 mg is verified, as well as the formulation challenges that can arise with materials such as poorly flowing spray-dried powders. The conversation also examines the potential implications of avoiding a mid-program formulation change, including what this could mean for development timelines and costs. Wagner and Rose address dosing considerations for both pediatric and adult populations and explore the capabilities a development partner needs to provide beyond the filling process itself.

Read the full interview to discover how they approach the potential path from first clinical trial to commercialization.