Guidance for Preclinical Studies with Radiopharmaceuticals

INTERNATIONAL ATOMIC ENERGY AGENCY

IAEA Radioisotopes and Radiopharmaceuticals Series No. 8

English STI/PUB/2031 ¦ 978-92-0-139322-7

129 pages ¦ 3 figures ¦ € 46.00 ¦ Date published: 2023

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Description

Preclinical or nonclinical evaluation is an integral part of the development of any drug. The process of developing a new radiopharmaceutical includes rigorous testing before it can be cleared for use in humans. There must be in-depth characterization of its behaviour to assess its safety and suitability for the intended clinical application. This publication provides a baseline guide for preclinical evaluation of radiopharmaceuticals that will give its readers a general review of the requirements of a facility and insight into the various scientific activities that constitute this process. The principles and protocols discussed herein will provide guidelines for biological assessment of candidate compounds, which are consistent with the principles of good laboratory practices to generate valid nonclinical scientific data towards approval for clinical translation. This publication is intended not only for researchers engaged in radiopharmaceutical development, but also for the Member States planning to set up or upgrade facilities for radiopharmaceuticals’ research.

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Keywords

IAEA Radioisotopes and Radiopharmaceuticals, Guidance, Preclinical Studies, Clinical Trials, Nuclear Medicine, Research, Preclinical Evaluation Process, Requirements, Scientific Activities, Biological Assessment, Radiopharmaceutical Development, Study Design, Preclinical Aspects, Quality Criteria, In Vitro Testing, In Vitro Assays, Tissue Based Assays, In Vitro Methods, In Vivo and Ex Vivo Testing, In Vitro in Cell, Serum Matrices, Evaluation Protocols, Baseline Procedures, Animal Models, Radioactivity Distribution Study, Radiometabolite Analysis, Toxicology, Guidelines, Dosimetry, Data Reporting, Data Management, Preclinical Scientific Data, Clinical Translation, Facilities Requirement, Equipment, Staffing Requirements, Training, Safety Considerations, Quality Assurance, Quality Control, Efficacy, Preclinical Imaging Scanners, Protocols, General Principles, Candidate Molecules, Good Laboratory Practices, Single Photon Emission Computed Tomography, SPECT, Positron Emission Tomography, PET, Member States