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The Clinical Translation Process in the United States

  • Sonia Sequeira
  • Serge K. LyashchenkoEmail author
Chapter

Abstract

This chapter presents strategies and practical guidance for the development and early clinical translation of radiopharmaceuticals for oncology in the United States, particularly for non-commercial, academic sponsors. Process planning, preclinical safety evaluation, product quality, clinical design, regulatory mechanisms, and the investigational new drug application are discussed. The principles presented apply to small molecule or biological molecular imaging probes, theranostic platforms, and radiotherapeutics and focus on first-in-human studies. It is hoped that this overview will help academic investigators navigate the regulatory system efficiently and safely.

Keywords

Chemistry, manufacturing, controls (CMC) US Food and Drug Administration (FDA) Good laboratory practices (GLP) Good manufacturing practices (GMP) Industry sponsors Institutional review board (IRB) Investigational new drug (IND) Application noncommercial sponsors Radiopharmaceuticals Clinical translation Drug development First-in-human clinical trial 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Research and Technology ManagementMemorial Sloan Kettering Cancer CenterNew YorkUSA
  2. 2.Department of RadiologyMemorial Sloan Kettering Cancer CenterNew YorkUSA

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