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

Choosing AMC resources vs outside consultants and vendors, leveraging local resources where possible. Qualifying and monitoring suppliers, testing laboratories, in-house departments, and Contract Drug Manufacturing Organizations (CDMO). Bringing together the deliverables for the IND CMC section. Whe...

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Detalles Bibliográficos
Autores principales: MacArthur, Robert Bruce, Rockwell, Kenneth, Johnson, Amber, Vaughan, Roger, Coller, Barry S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2020
Materias:
Commercialization/Entrepreneurship
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8823355/
http://dx.doi.org/10.1017/cts.2020.161

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8823355/
http://dx.doi.org/10.1017/cts.2020.161

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