Mediford Corporation offers an extensive menu of in vivo and in vitro pharmacokinetic testing services that are conducted in accordance with Standards of Reliability of Application Data (Pharmaceuticals and Medical Devices Act), OECD GLP and GLP for agricultural chemicals under an operational management system that has been confirmed as GLP-compliant through inspections by domestic and foreign regulatory authorities on safety studies of pharmaceuticals and agricultural chemicals. In particular, our skin permeability studies in accordance with GLP for agricultural chemicals have been well received as one of our frontline services.
We continue to satisfy the diverse needs in various aspects of our clients’ research and development projects while keeping an eye on the latest technologies, various guidelines, and regulation trends. Please contact us with any inquiries or requests.
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.
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.
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.
We evaluate the protein binding rate of the test substance in vitro. In vivo evaluation is also possible in experimental animals.
We evaluate the blood cell distribution of the test substance in vitro. In vivo evaluation can also be performed on experimental animals.
We evaluate the effect of the test substance on drug metabolizing enzymes in vitro using human liver microsomes.
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.
We evaluate the effects of the test substance on drug metabolizing enzymes in vitro using human hepatocytes.
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.
We perform metabolite profiling in plasma, urine, feces, bile and organs obtained from animals treated with the test substance.
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.
We provide technical guidance on ADME experiments (administration of RI labeled compounds, blood sampling, QWBA, and tissue, urine, feces, bile collection etc.).
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.