4324 Phase 1 Sterile Product Formulation and Manufacturing at Academic Medical Centers: An Introduction for Translational Researchers

OBJECTIVES/GOALS: To facilitate the development of innovative injection products by providing translational researchers with a regulatory and manufacturing road map for producing small batch sterile products for Phase 1 research use. To leverage recent AMC investments in facility improvements and ph...

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Bibliographic Details
Main Authors: Robert Bruce MacArthur, Kenneth Rockwell, Amber Johnson, Roger Vaughan, Barry S. Coller
Format: Article
Language:English
Published: Cambridge University Press 2020-06-01
Series:Journal of Clinical and Translational Science
Online Access:https://www.cambridge.org/core/product/identifier/S2059866120001612/type/journal_article