Nonclinical and Clinical Services

Bioanalysis Services

Based on the company’s extensive experience we are able to provide support for improving the speed of the drug development process. Using the latest technology and equipment, centered primarily on the use of LC/MS/MS, we are able to carry out all suitable measurements at our GLP-compliant facility, and also we have experience of validation of over 100 different measurements each year.

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

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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