Practical Guidelines for Preclinical Experiments for Accelerator-Based BNCT Systems. Annex XVIII

This article is intended to guide practical planning of preclinical tests before conducting clinical trials for accelerator-based boron neutron capture therapy (AB-BNCT). Pre-planning of clinical trials for treatment of specific types of cancers with AB-BNCT is necessary to make preclinical evaluation plans for discussion with the regulatory authorities. For different types of AB-BNCT systems, the assessment of safety and effectiveness and evaluations may need to be different. In this article, the current guidelines of set up conditions for AB-BNCT systems and necessary considerations are discussed. (author)