Toxicity and toxicokinetic considerations in product development and drug research

Toxicokinetics (TK) is regarded as the kinetics study of absorption, distribution, metabolism, and excretion of a xenobiotic(s) carried out under the conditions necessary for evaluation of toxicity. It is budding as a significant tool and playing an important role in the progression of product discovery and development. TK is found to be applicable in evaluation of toxicity of said molecules or system and its interpretation in an animal study to obtain toxicological data. TK has become part of the drug discovery and development through the implementation of the International Conference on Harmonization guidelines provided for the systemic exposure and selection of dose. To gather the information about the toxicological data of xenobiotic(s) and chemicals used in the preparation of formulations, we need to learn and understand the target organs, doses required for these target organs, effective mechanisms at these doses, and the chemical nature and properties of the materials used to observe their effects on the health. This chapter discusses about the principles involved in TK studies, their applications, significance in drug development stages, and approaches to reduce the number of animals used in the TK studies.