Pharma Considerations for Timely Development of Therapeutic Radiopharmaceuticals

Part of the Medical Radiology book series (MEDRAD)


The practical aspects of systemic radiotherapy development are a hybrid between that of more traditional oncology drug development and aspects of radiation oncology. Systemic radiotherapeutics (those directly administered in an unsealed source form) are drugs and are regulated as such whereas brachytherapy (sealed) sources are regulated as devices. The regulatory development path for drugs is well defined with some special provisions for oncology drugs. Systemic radiotherapeutics are accommodated by the existing regulations quite well but there are some differences. The regulations leading to drug approval are one of the major drivers of the differences between early academic or commercial development and later efforts. To understand these differences it is necessary to understand the effect of the drivers. This chapter will outline the pathways and the differences that are taken into consideration by pharma when developing a systemic radiotherapeutic agent.


Maximum Tolerate Dose Bystander Effect Systemic Radiotherapy Oncology Drug Cold Formulation 


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Copyright information

© Springer-Verlag Berlin Heidelberg  2012

Authors and Affiliations

  1. 1.Bracco Research USA LtdPrincetonUSA

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