Nonclinical and Clinical ServicesWe have renewed our web page for Nonclinical Services. Please find the link hereWe have renewed our web page for Chemical Substance Management. Please find the link here

Nonclinical Studies

The Toxicological Science Division serves to perform nonclinical studies by taking full advantages of a vast array of techniques and renowned reliability that the former Mitsubishi Chemical Safety Institute Ltd. (MSI) had acquired through its broad range of accumulated experience.

Tests on Pharmaceuticals and Agrochemicals

  • 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

Equipment

  • LC-MS/MS

    • Quantum
    • Quattro Premier
    • Xevo TQMS
    • API 3000
    • API 4000
    • API 5000
    • 4000QTRAP
    • Triple Quad 5500
  • GC/MS

    • Agilent
  • HPLC

    • SHIMADZU
    • HITACHI
    • Waters

All of our research and studies are in strict adherence to the laws concerning protection and management of animals with full respect of the standards concerning care and management of test animals, and have been accepted and certified for animal welfare practices.



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