Nonclinical and Clinical ServicesWe have renewed our web page for Nonclinical Services. 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

Pharmacokinetic Studies

Our pharmacokinetic studies are performed in reference to the reliability standards under the same quality and accuracy system as for GLP compliant and certified safety studies of pharmaceuticals, agrochemicals, and industrial chemicals.
Pharmacokinetic studies in reference to the OECD GLP are available to satisfy the requirements for the registration in USA and EU.

In Vivo Tests

Various animal studies are available using RI-labeled compounds and non-labeled compounds. Our absorption, distribution, metabolism and excretion (ADME) studies with RI-labeled compounds are assisted by GLP compliant computer system (ADME SUPPORT, FFC).

In Vitro Tests

We perform various tests using biological samples, microsomes, various cell lines, and hepatocytes obtained from human donors and animals.

  1. In Vitro Metabolism Studies
  2. Identification of CYP Isoforms Involved in Drug Metabolism
  3. Drug Interaction
  4. Inhibition of Drug Metabolizing Enzymes
  5. Protein Binding Studies
  6. Blood Distribution
  7. Transporter Studies
  8. Percutaneous Absorption Studies in Rodents and Non-Rodents
  9. Membrane Permeability Studies with Caco-2 cells

Isolation, Determination, and Structure Elucidation of Metabolites

We perform isolation, determination, and structure elucidation of metabolites in biological samples and reaction solutions obtained from in vivo and in vitro tests. All equipment is applicable to RI-labeled compounds.

  1. Isolation and Determination of Metabolites with Radio-HPLC and TLC-RLG Methods
  2. Structure Elucidation of Metabolites with Mass Spectrometry such as LC/MS/MS
  3. Structure Elucidation of Metabolites with Nuclear Magnetic Resonance Spectrometry (NMR) such as 1H-NMR and 13C-NMR

Ex Vivo Drug Metabolizing Enzyme Induction Tests

We can analyze drug metabolizing enzyme activities and identify P450 enzymes with liver samples etc. obtained in toxicity studies.

Others

  1. Pharmacokinetic Analysis (WinNonlin)
  2. Statistical Analysis (SAS, JMP)
  3. Multisite Tests (Multisite tests are available upon request)

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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