Pharmacokinetic Study

We started offering Pharmacoinetc (PK) studies in 1971. With over 50 years of experience and accumulated knowledge, we offer various PK studies including the use of pathological animals that will fit your needs in the drug development.

Our Regulatory 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.
  • 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.

Please contact us for other isotopes, animal species and administration routes.

In vivo studies (using non-labeled compounds)

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

In vitro

  1. 3.Species Comparison

    We examine and compare metabolite production and decrease in parent compound in various animal species (mouse, rat, dog, monkey and human) using liver microsome, liver S9, cytosol or hepatocyte. Examination using other cell fractions (kidney, small intestine and lung, etc.) are also available.

  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

    The binding rate of the drug candidate to humans or animal plasma protein is determined using ultrafiltration, equilibrium dialysis or ultracentrifugation method.
    Affinity of the drug candidate to HSA, α1-AGP and IgG along with its binding site and the number can also be determined.