The Challenges And Opportunities Of Pediatric Dosage Form Development: Part 2 - Taste/PK Assessments, Clinical Supplies And Commercial Manufacturing

By Nazim Kanji, Executive Director, Pediatric Services, Quotient Sciences

In Part 1 of our two-part blog piece, Quotient’s Executive Director of Pediatric Services, Nazim Kanji, covered key considerations in pediatric program design and formulation development strategies that sponsors should take into account if they want to successfully bridge from initial concept into later stages of development and through to commercialization.

Given that in-house Large Pharma and the CMO service sector have traditionally focused on high-volume and low-variation drug products, there is an emerging industry need for smaller-scale, batch manufacturing.

This blog reviews: adult taste/PK study, clinical supplies for pediatric patient trials, and commercial manufacture.