Introduction

While pharmacokinetics is considered to be the kinetic form of efficacious medicine that enters body in the course of absorption, distribution, metabolism and elimination, it is toxicokinetics test that focus on occurrence of toxicity such as side effect of medicine or chemical substance as one of qualities in pharmacokinetics by emphasizing the toxicity of safety amount in the toxicity test. The toxicokinetics of ICH has established a test to evaluate the whole exposure, which is mandatory as the formation element of clinical testing or using the planned subtest to acquire toxicokinetic data.

Pharmacokinetics

The test performs procedures related to absorption/distribution/metabolism/excretion while evaluating the kinetic movement from the exposure of test substances to excretion at the efficacious level of concentration. In addition, by using bioavailability, we can find the data to support the research of test substances. Generally, HPLC, LC/MS/MS analysis gives accurate results.

Toxicokinetics

The origin that differentiates the occurrence of toxicity can be classified by the difference of reactions on pharmacokinetics such as the absorption of drugs, distribution, metabolism and excretion. Therefore we can evaluate the in vivo kinetics of the drugs, especially the blood concentration to decide the adequacy of toxicity testing and to extrapolate the results to human body. Generally, HPLC, LC/MS/MS analysis gives accurate results.

Items of Measurement

- Plasma/urine/excretion/metabolomic analysis
- Distribution test throughout certain tissue analysis
- Various toxicity tests along with toxicokinetic test