Non-clinical safety study of radiopharmaceuticals is to make overall evaluation of the potential toxicity of all components in the samples to be used in clinical trials and/or samples to be marketed, including toxicology, radiation safety, etc., and provide supporting data information for safety evaluation of final products.
As the safety evaluation of radiopharmaceuticals is a necessary procedure and an important step before new drugs enter the final clinical trial and final approval, the State Food and Drug Administration requires preclinical toxicology evaluation to determine the toxicological characteristics of new candidate drugs before the first human study. Therefore, United Well strictly abides by the requirements of Good Laboratory Practice in the safety evaluation of radiopharmaceuticals, ensuring that variables are minimized, and controlling and monitoring are carried out according to appropriate guidance and standard operating procedures (SOPs).
United Well radiopharmaceutical safety evaluation laboratory plays a very important role in the non-clinical safety evaluation of drugs.
For pre-clinical candidates (PCC) or IND, GLP toxicology study can conduct a comprehensive drug safety evaluation.
For early compound study, early diagnosis test (EDT) can reduce the risks and costs related to preclinical safety assessment by detecting and eliminating potential toxic drug candidates as early as possible.