Service Details
Pharmacokinetic Studies
ADME studies (Absorption, Distribution, Metabolism, Excretion)
We conduct pharmacokinetic studies (absorption, distribution, metabolism, and excretion studies using various types of animals) in compliance with Standards of Reliability of Application Data (Pharmaceuticals and Medical Devices Act), GLP for agricultural chemicals, and OECD GLP at GLP-compliant facilities that have obtained AAALAC accreditation. Measurement data are collected and calculated online by a validated pharmacokinetic study support system to ensure Data Integrity.
Placental/Fetal transfer, milk secretion
We measure tissue radioactivity levels in pregnant rats (during organogenesis and perinatal period).
Tissue excision and QWBA methods are available for evaluation.
We also measure the radioactivity concentration in milk and plasma of lactating rats over time to evaluate the transfer of the test substance into milk.
Pharmacokinetic study using human liver chimeric mice
We measure and analyze metabolites in biological samples by administering test substances to mice transplanted with normal human hepatocytes (human liver chimeric mice). We help reduce risks in drug development by confirming the presence of human-specific metabolite formation in vivo at an early stage.
We can also conduct pharmacokinetic studies using various pathological models based on the technologies for creating pathological models that we have built up in the course of conducting contract pharmacology studies. Please contact us for more information on applicable pathological models.
Plasma protein binding
We evaluate the protein binding rate of the test substance in vitro. In vivo evaluation is also possible in experimental animals.
- Evaluation animals
- Humans, monkeys, dogs, rabbits, rats, mice, etc.
- Sample
- Plasma, serum, and purified protein (albumin, α1-acid glycoprotein, γ-globulin, etc.)
- Evaluation method
- Ultrafiltration, ultracentrifugation, and equilibrium dialysis
- Evaluation items
- Protein binding rate, identification of bound proteins, etc.
Blood cell distribution
We evaluate the blood cell distribution of the test substance in vitro. In vivo evaluation can also be performed on experimental animals.
- Evaluation animals
- Humans, monkeys, dogs, rabbits, rats, mice, etc.
- Sample
- Fresh blood
- Evaluation items:
- Blood cell distribution (%), and blood/plasma concentration ratio (Rb)
Drug-metabolizing enzyme inhibition
We evaluate the effect of the test substance on drug metabolizing enzymes in vitro using human liver microsomes.
- Enzyme source
- Human liver microsomes
- Measurement method
- LC/MS/MS
- Enzymes evaluated
- CYP, UGT, etc.
- Evaluation items
- Drug interactions related to metabolic inhibition
Drug-metabolizing enzyme and isoform identification
We evaluate the enzymes and isoforms involved in the metabolism of the test substance in vitro using cell fractions prepared from human liver and expression systems for each drug-metabolizing enzyme.
Identification of drug metabolizing enzymes
- Enzymes evaluated
- CYP, UGT, FMO, GST, etc.
- Enzyme sources
- Human liver microsomes, human liver cytosol, human liver S9, various expressing enzymes (CYP, FMO, UGT)
- Evaluation items
- Cofactor requirement (CYP, FMO, UGT, ST, GST), metabolism by expressing enzymes (CYP, UGT, FMO), inhibition of activity by specific inhibitors (CYP, FMO)
Identification of CYP isoforms
- Enzyme evaluated
- CYP
- Enzyme sources
- Human liver microsomes, CYP-expressing enzymes
- Evaluation items
- Identification using human CYP-expressing microsomes, identification using inhibitors, identification by correlation analysis
In vitro human CYP induction
We evaluate the effects of the test substance on drug metabolizing enzymes in vitro using human hepatocytes.
- Evaluation item
- Induction of CYP activities by measuring mRNA expression levels.
In vitro skin permeability
We evaluate skin permeability and transitivity of the test substance in vitro using human and experimental animal skin. In combination with in vivo (rat) dermal dosing studies, dermal absorption rates can also be estimated in humans in vivo (triple-pack). Test results required for pesticide registration (including reevaluation) are obtained in compliance with GLP standards for pesticides.
Metabolite profiling
In vivo metabolite profiling
We perform metabolite profiling in plasma, urine, feces, bile and organs obtained from animals treated with the test substance.
- Animals used
- Mice, rats, dogs, monkeys, rabbits, etc.
In vitro metabolite profiling
We perform in vitro metabolite profiling using hepatocytes or cell fractions from humans and various experimental animals to evaluate species and sex differences in the metabolism of the test substance.
- Animals used
- Humans, mice, rats, dogs, monkeys, rabbits, etc.
- Enzyme source
- Hepatocytes, microsomes (liver, kidney, small intestine, etc.), and S9 (liver, kidney, etc.)"
Data Management System
We utilize a centralized data management system known as SDMS (Scientific Data Management System) to manage measurement data from various instruments, including electronic balances, LCMS, and liquid scintillation counters, on a server. This system enables data management with electronic signatures in accordance with unified regulations, as well as verification of audit trails. Additionally, it allows for the combination of data from different instruments to calculate results, establishing an advanced data integrity (DI) framework that manages everything from data acquisition to report generation within a single system.
Other Services
Knowledge service
We provide technical guidance on ADME experiments (administration of RI labeled compounds, blood sampling, QWBA, and tissue, urine, feces, bile collection etc.).
Partnership with Nemoto Science Co., Ltd.
Mediford Corporation and Nemoto Science have signed a mutual master subcontract agreement for ADME Studies. This enables us to propose more various techniques and flexible timelines for studies.