How To Solve Complex Pediatric Dosing Challenges Using Tailored Solutions

By: Dave Miller, Ph.D., Chief Scientific Officer, AustinPx

Pediatric drug development presents a layered set of challenges: flexibility requirements for weight-based dosing, taste masking for notoriously bitter APIs, and patient-friendly formats that encourage compliance. Add in regulatory scrutiny and manufacturing complexity, and it’s clear that pediatric drug development is more than just making a smaller dose for a smaller person. It requires customized development strategies, specialized capabilities, and cross-functional expertise.

Moreover, most CDMOs are not equipped for the complexities of pediatric drug development. While many offer standard formulation services, few possess the scientific depth, real-world experience, and technical capabilities required to engineer and manufacture a pediatric product to exact specifications.

At AustinPx, we approach pediatric formulation with that full complexity in mind. Every decision we make is grounded in a wider view that weighs technical feasibility alongside regulatory, manufacturing, and commercial impact. We do not solve for isolated challenges. We build solutions that hold up across the entire development journey.