IPQ’s five part series is exploring the need for: ● a more qualified-for-purpose excipient toolbox that can help address the formulation, quality, and manufacturing challenges posed by a new generation of medicines, and ● a regulatory process that can better accommodate novel excipients.
PART I: FDA’S Novel Excipient Program Proposal and Stakeholder Comments
PART II: IPEC/IQ Thought Leaders on the Novel Excipient Drivers
PART III: Subcutaneous Biotherapeutics, Pediatrics, and Delayed Release
PART IV: USP Initiatives Supporting Novel Excipient Development
PART V: Assessing and Managing Excipient Risks