Abstract
This article briefly discusses the new drug approval process with emphasis on the chemistry, manufacturing and controls portions of investigational new drug (IND) applications and new drug applications (NDA).
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R.J. Bayly, E.A. Evans, and J.S. Glover, Synthesis of Labeled Compounds in_Radiopharmacy, M. Tubis and W. Wolf, Ed., J. Wiley and Sons, New York, NY, 1976, pages 306–307.
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© 1991 Springer Science+Business Media New York
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Sheinin, E.B., Kishore, R. (1991). New Drug Approval Process for Radiopharmaceuticals. In: Emran, A.M. (eds) New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-0626-7_48
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DOI: https://doi.org/10.1007/978-1-4899-0626-7_48
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4899-0628-1
Online ISBN: 978-1-4899-0626-7
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