Conduct of Research
Toward Public Health & Safe Society
Toxicokinetics Test
Pharmacokinetics & Toxicokinetics
Pharmacokinetics and toxicokinetics test each studies the property pharmacokinetics of medicinal effect dose and toxicity dose to provide objective data to risk assessment such as medicinal effect and toxicity existence also necessary information for setting clinical injection dose. Pharmacokinetics provides nonclinical test data which is necessary data for approval at the stage of developing drug, chemicals, agricultural pesticides and biotechnology products.
We conduct credible test in accordance with guidelines of Korea(KFDA), US(FDA), Japan(MHLW and ICH based on GLP appropriate facility, professional resources and operation system.
Field of Test
Toxicokinetics
- In nonclinical test, to assess the internal exposure of test substance, the test injects toxic dose of test substance to assess the internal kinetics
- Toxicokinetics research on toxicity tests such as general toxicity test(single, repeated dose toxicity test), carcinogenicity test, reproductive toxicity test, non-human primates toxicology test
Pharmacokinetics
- Use rodents, non-rodents and non-human primate to analyze the concentration of drug in blood, tissue, urine and excrement to predict and assess the absorption, distribution, metabolism and excretion of drug
- Pharmacokinetics test using beagle and non-human primate
Method Development
- Choose chromatographic method or ligand-binding assay method in accordance with drug property and develop the optimal analysis method to quantify the drug in specific matrix
- Bioanalytical method development of drug and metabolome from specimen
- Formulation analysis method development
Method Validation
- Conduct validation on developed drug analysis method in accordance with FDA guidance, EMEA guideline or ICH guideline
- Bioanalytical method validation of drug and metabolome from specimen
- Formulation analysis method development
Bioanalysis
- To conduct new drug candidate substance or metabolome analysis existing in blood and tissue from toxicokinetics/pharmacokinetics test, use the identified analysis method with analysis device and quantify the sample
- Content, stability and homogenity test in formulation
Formulation analysis
- Test the content, stability, homogenity of formulation injected in toxicity test
- Feasibility test
- Conduct feasibility test in case of receiving valid analysis method from the client to check if the method is applicable, and decide proceeding the analysis method validation test
Related to chromatographic Department in charge : Bioanalysis and Pharmacokinetics Research Group | Inquiry department : Industry Support Team | Tel : 042-610-8169, 042-610-8080
Related to Ligand-binding assay Department in charge : Bioanalytical and Immunoanalytical Research Group | Inquiry department : Industry Support Team | Tel : 042-610-8169, 042-610-8080