The use of micro-dosing in clinical formulations is increasing as firms wrestle with how to get their new oral drug products to the clinic as quickly as possible with the fewest regulatory hurdles.
The challenges of moving a new chemical entity (NCE) into the patient more quickly, and the pros and cons of traditional methods versus more recent approaches that take advantage of advances in “micro-dosing” technology, were analyzed by presenters at a webinar on “Accelerating the Timeline to First-in-Human Trials” sponsored by Pharmaceutical Formulation & Quality and Capsugel in mid-July.
In the webinar, Pharmatek Laboratories CEO and co-founder Tim Scott, AMRI Pharmaceutical Development Manager Joseph Forth, and Capsugel Pharmaceutical Technology Director David Edwards explored the use of several competing dosing and formulation technologies and their impact on the CMC regulatory process and development timelines.
Scott explained that he was using the term “micro-dosing” to refer to “putting powder neat into a capsule” as opposed to the use of the term in “Phase 0” clinical trials that are typically done for PK analysis.
[More from the webinar participants on the advantages and disadvantages of micro-dosing versus more traditional approaches and the impact on oral product development timelines is provided for subscribers here.]