Evaluation of Radiopharmaceutical

Evaluation of Radiopharmaceutical

The CIRPTC Platform for Preclinical R&D and Transformation of Radiopharmaceutical, approved by China Atomic Energy Agency (CAEA) as the CAEA Center of Excellence on Nuclear Technology Applications for Nonclinical Evaluation for Radiopharmaceutical, mainly carries out non-clinical safety evaluation and early screening of radiopharmaceuticals, as well as treatment for radiation injuries and research on radiotherapy technologies.

01 Preclinical Evaluation of Radiopharmaceutical

The Safety Evaluation Center for Pharmaceutical within the framework of the Platform obtained the GLP accreditation from National Medical Products Administration (NMPA) in March 2006, and further passed the GLP accreditation for radiopharmaceuticals in 2020, becoming the first unit in China to have preclinical safety evaluation qualification for radiopharmaceuticals.

Below experiments could be done at the platform:

Pharmaceutical Safety Assessment 1

02 Early Screening and Microdose for Radiopharmaceutical

  • Radiolabeling: Study on labeling technologies for commonly used medical radionuclides, targeted polypeptide and protein pharmaceuticals, such as 99mTc, 125I, 177LU, 68Ga, and 64CU.
  • Development of radiochemical purity analysis methods: Studying parameters such as developing agent type, chromatographic paper type, RF value, etc.
  • Cellular-level binding assay experiment: Target binding rate study
  • Animal-level tissue distribution test: Study on the in-vivo distribution of radionuclide-labeled pharmaceuticals (Imaging methods: PET, SPECT, autoradiography; Experimental analysis methods: Sample oxidizer, liquid and solid scintillation counter, γ-counter)
Pharmaceutical Safety Assessment 2

03 Separation and Purification of Radionuclides

Extraction of alpha radionuclides for radiotherapy from natural thorium series has also been developed at CIRP. Radiochemical separation and purification process of 228Ra, 228Th, 224Ra, 212Pb were established. The separated alpha emitters 224Ra, 212Pb and 212Bi satisfy the needs of early research on targeted alpha therapy. Concerning of the applications of 14C-urea breath test, radionuclide purity assay method of 14C-urea capsule and 14CO2 detection technique were also developed, and a series of plastic scintillation microspheres which can be used for on-line radionuclide determination has been synthesized.

Pharmaceutical Safety Assessment 3

04 Dosimetry and Evaluation in Precision Radiotherpy

The Scintillator 3D Dosimetry Device developed by CIRP can measure the 3D dose field distribution in real time with a sub-millimeter resolution. The novel technology is promising in dose verification of precision radiotherapy.


  • Low cost       
  • High speed: <5 mins
  • Real time: per second
  • Tissue equivalence: A+
  • High resolution: sub-millimeter
Pharmaceutical Safety Assessment 4

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