CDE Dosimetry Services

Accelerating the Development of Radiopharmaceuticals

Our Services Include:

  • Clinical Study Design:
    • Guidance for the setup of pre-clinical and clinical dosimetry studies.
  • Protocol and Associated Document Development:
    • Complete production of dosimetry section of study protocols
    • Complete production of project specific dosimetry SOPs
    • Complete production of dosimetry manual
    • Guidance for dosimetry requirements in image acquisition manuals.
    • Review of final protocol for dosimetry purposes
  • Treatment Planning Dosimetry Analysis:
    • Clinical determination of individual dosimetry estimatesfor the purpose of treatment planning.
  • Determination of dosimetry for both pre-clinical and clinical studies, both therapeutic and diagnostic, which includes:
  • Creation of project specific fully validated dosimetry calculational tools. constructed under the standard compliance guidelines.
  • Animal to human data extrapolation for pre-clinical studies.
  • Full ROI construction on conjugate whole body planar images, SPECT images, PET images, and transmission images.
  • Patient-specific organ volume determination from CT
  • Image quantification under the relevant guidelines, with or without scatter, attenuation, and background correction where applicable.
  • Analysis and extrapolation of blood and urine data for dosimetry.
  • Kinetic modeling of resultant biodistribution data.
  • Production of final dosimetry estimates.
  • All dosimetry analysis is completed using FDA cleared and/or fully validated software packages and dosimetry tools, including the FDA cleared OLINDA/EXM software, of which CDE lead dosimetrist Dr. Richard Sparks is a co-author.
  • Comprehensive documented quality assurance and audit trails of both intermediate and final dosimetry results.