Pharmacokinetic Study

Based on expertise that has been accumulated since the start of contract pharmacokinetic studies in 1971, we conduct various such studies.
Please contact us about conducting a kinetic study using pathologic animals.

Applicable standards

  • Article 43 "Quality Assurance Standard for application materials," Enforcement Regulation of the Japanese Pharmaceutical Affairs Law (MHW Ordinance No.1)
  • OECD Principles on Good Laboratory Practice (revised 1997, Issued Jan 1998)
    ENV/MC/CHEM (98) 17

We conduct absorption, distribution, metabolism and excretion studies using various animal species.

  • Isotope: 14C, 3H, 125I, etc.

For the other isotopes, please ask us.

  • Animal species: rat, mouse, dog, monkey and miniature pig
  • Administration route: oral, intravenous, continuous intravenous, transdermal, subcutaneous, intramuscular, intratracheal, instillation, intrarectal and intraduodenal administrations, etc.

For the other administration routes, please ask us.
(e.g.: nasal, intra-aqueous chamber, intra-hepatic artery, intra-hepatic vein, intra-articulatio genus, etc.)

In vivo (studies using non-labeled compounds)

We conduct enzyme induction studies (rat) and drug concentration determination.

In vitro

  1. 3.Comparative metabolism study among various animal species

    We examine and compare metabolite production/decrease in unchanged compound level among animal species (derived from mouse, rat, dog, monkey, human) using liver microsome, liver S9, cytosol and hepatocyte. Examination using cell fractions from non-liver tissues (kidney, small intestine and lung, etc.) is possible.

  2. 4.Enzyme induction study

    We evaluate induction activity for the drug metabolizing enzyme of a candidate compound by measurements of enzymatic activity or mRNA level using frozen or non-frozen human culture hepatocytes.

  3. 5.Protein binding

    We determine plasma the protein binding rate of a candidate compound in various animals and human by a number of study methods such as the equilibrium dialysis method, ultrafiltration method and ultracentrifugal method. The candidate’s affinity to HSA, α1-AGP and IgG, their binding sites and the number of such site can also be determined.