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.
The Drug Development Solutions Center is fully accredited by AAALAC International (The Association for Assessment and Accreditation of Laboratory Animal Care International) to accommodate requirements set by the agencies for the animal welfare.
Our Regulatory Standards
- Article 43: Reliability Criteria of the Date Attached to New Drug Applications, Regulation of Pharmaceutical and Medical Device Act (Ordinance No. 1 of the Ministry of Health, Labour and Welfare).
- OECD Principles on Good Laboratory Practice (revised 2021, issued Sep. 2021) ENV/MONO (2021) 26
In vivo studies (using radiolabeled compounds)
We conduct absorption, distribution, metabolism and excretion studies using various animal species.
- Radionuclides: 3H, 14C, 35S, 51Cr, 90Y, 111In, 125I and more
- Animal species: mouse, rat, rabbit, dog, miniture pig, and monkey
- 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 development of analytical method, administration of drug candidate and also collction of samples.
- 1Estimation/Inhibition of CYP species
We can identify metabolic enzymes responsible for the metabolism of the drug candidate using various enzyme expression systems or human liver microsomes with and without P450 specific inhibitors.
- 2Transporter study
We investigate if a drug candidate can be a substrate of various transporters by using transporter expressing cells, vesicles or cryopreserved hepatocytes. We examine the inhibitor potential of the drug candidate using a probe substrate and compare by inhibition by typical inhibitor to calculate inhibition constants (IC50 or Ki). We have an extensive portfolio of ABC and SLC transporters.
- 3Species 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.
- 4Enzyme induction study
By using cryopreserved human hepatocytes, potential of a drug candidate to induce the expression of drug-metabolizing enzymes (CYP1A2, CYP2B6 and CYP3A4) will be determined by measuring the enzyme activities or mRNA expressions.
- 5Protein 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.