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Concentration Measurement under Various Regurations for Non-Clinical and Clinical Tests

SCAS conducts various concentration measurements based on our extensive experience and in compliance with GLP, Japanese regulation for approval application as required in drug development, and other domestic and international regulations.

Features

Our measurements including systems such as state-of-the-art LC‐MS/MS, HPLC, ELISA and ECL are conducted in compliance with domestic and international regulations.

  • Method validation(main items: specificity, linearity, lower limit of quantitation, inter-day reproducibility ,intra-day reproducibility, recovery, freeze-thaw stability, stability in autosampler, room temperature stability, storage stability, dilution integrity)
  • Clinical specimen measurement, TK, PK

Analysis for metals under various regulations using ICP‐MS and ICP‐AES.

  • Method validation
  • Clinical specimen measurement, TK, PK (examples: quantitative analysis of manganese and bismuth in plasma, quantitative analysis of gadolinium in urine, measurement of platinum in plasma and tissue, etc.)

Protocols, final reports

  • Documents can be provided in Japanese and English.

Study implementation system

  1. GLP (Ministerial Ordinance of the Ministry of Health, Labor and Welfare, No. 21) "Ministerial Ordinance Concerning the Standards for the Conduct of Non-clinical Studies on the Safety of Drugs"
  2. Reliability standard implementation system (Law Enforcement Regulation No. 43 Concerning Quality, Effectiveness and Safety of Medical Products and Medical Equipment)

Instruments

LC-MS/MS system MS/MS : API4000, API5000
Triple Quad 6500, Q TRAP 6500
GC-MS system
ICP-MS, ICP-AES,  ELISA, ECL, SPR, Microplate Reader, Microbead array, PCR etc

Other Analytical Technology Informations

Our Experience

  1. Contracted by more than 60 companies
  2. Tested items
    Pharmaceutical candidate compounds, Over-the-counter drugs, endogenous substances, etc.

Contact Us for Services

For inquiries and requests concerning services of analysis, measurements, products and consulting , please feel free to contact us via inquiry form or telephone/fax .

Telephone
+81-3-5689-1219
FAX
+81-3-5689-1222