Medical News

  Toxicokinetics is an essential element of preclinical studies of drugs. As an interdisciplinary discipline between pharmacokinetics and toxicology, toxicokinetics is a bridge and tool for advancing preclinical studies to clinical studies. The primary goal of toxicokinetic studies is to demonstrate the systematic exposure levels of new drugs in test animals during safety evaluation and their correlation with the administered dose and the course over time. Their studies generally include single-dose studies in toxicity studies, multiple-dose studies, tissue distribution studies, genotoxicity studies, carcinogenicity tests, reproductive toxicity studies, and toxicokinetic studies for specific drugs such as biotechnology. Toxicokinetics is based on pharmacokinetic studies, with the help of its methods and tools, to help evaluate drug safety and regulate research behavior according to GLP. As new drug research progresses, some compounds to be selected (both small and large molecules)...

 In drug development, many compounds often die in clinical trials because of the toxicity or safety of their metabolites, among which the active metabolites formed by drug molecules activated by human liver metabolism are more likely to be an important cause of toxicity.  In vivo or in vitro metabolite analysis of drugs can be used to determine an early stage whether a compound is toxic and suitable for further development, thus minimizing unnecessary losses. In preclinical drug metabolite analysis and metabolite structure identification to evaluate the safety of a drug metabolite, one can identify an animal species in a routine toxicology test in which adequate exposure levels of that metabolite can be formed, which is comparable to or higher than human exposure, and then study the drug toxicity in that animal species. Alternatively, if a relevant animal species cannot be identified that forms the metabolite, the metabolite can be synthesized, and further safety evaluations ...