CMC and GxP
Book Title
Translational Interventional Radiology
Files
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Editors
Eltorai AEM, Liu T, Chand R, Kalva SP
Description
This chapter focuses on chemistry, manufacturing, and controls (CMC) and Good “x” Practices (GxP) of investigational new drug applications. Pharmaceutical drug development necessitates a review of relevant CMC details. Review of the CMC details ensures identity, quality, safety, and stability of drug products before commercialization. Examples of CMC applications are provided in the context of drugs used in interventional radiology. Common challenges with CMC applications include insufficient information regarding safety and purity of pharmaceuticals and inconsistent pharmaceutical production practices. GxP provides regulations to ensure the safety of drug products throughout their manufacturing, storage, and distribution.
First Page
425
Last Page
429
ISBN
978-0-12-823026-8
Publication Date
2023
Publisher
Academic Press
City
Cambridge, MA
Keywords
chemistry, manufacturing, controls, good 'x' practices, pharmaceuticals
Disciplines
Radiology
Recommended Citation
Espiritu M, Mehta CTI, Dixit PK. CMC and GxP. In: Eltorai AEM, Liu T, Chand R, Kalva SP, editors. Translational and interventional radiology. Cambridge (MA): Academic Press; 2023. p. 425-429. doi:10.1016/B978-0-12-823026-8.00061-4. (Handbook for Designing and Conducting Clinical and Translational Research).
Comments
Chapter 86