• TK/PK analysis

  Analysis of drug and its metabolites in human and animal samples

Development of measurement system

• Based on character of drug structures or on your/clients information, we develop a measurement system that is based on LC/MS. Investigation is subsequently performed using the pretreatment method of the sample and analytical conditions of the equipment.

Validation of analytical techniques

• Measurement techniques developed by the company essentially follow the FDA’s Bioanalytical Method Validation, in being subject to validation. These techniques are tested using various conditions such as examining the stability of target object in blood, in preparation for use in actual clinical testing.

Operation of measurement

• Following validated measurement techniques, measurement is carried out in line with GLP. The TK studies are available under the same quality and reliability levels as our GLP compliant and certified safety studies in the Kashima and Kumamoto Laboratories. We have a broad range of experience with all sorts of different animals.

Nonclinical PK studies

• Blood Kinetic Tests, Bioavailability Tests, Biological Equivalence Tests, and Drug Interaction Tests in vivo are available in Kashima and Kumamoto Laboratories.

MultiSite Tests

Assay of Biomarker

PD and safety markers and Drug concentration Measurement of Protein Therapeutics are available in the Advanced Medical Science Research Center

• For details

Equipment