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...
Main Authors: | , , , , |
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Format: | Article |
Language: | English |
Published: |
Cambridge University Press
2020-06-01
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Series: | Journal of Clinical and Translational Science |
Online Access: | https://www.cambridge.org/core/product/identifier/S2059866120001612/type/journal_article |