The main goal of toxicokinetic studies is to establish a correlation between the compound concentration or dose and potential adverse effects and to aid in understanding the mechanisms of toxicity. Repeated dose toxicity studies in animals are performed for this purpose. Evaluation of various pharmacodynamic (adverse effects) and pharmacokinetics (absorption, biodistribution/accumulation, metabolism, excretion) parameters is usually performed after the first and last injection of the compound or drug candidate. Compound concentration in plasma is measured using the HPLC-MS/MS method. At Bienta, toxicokinetics studies are carried out in accordance with OECD 417 guidelines.
Typically, DRF is the first stage of a toxicokinetics study.