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AAALAC Accredited In Vivo Animal ADME Studies

Radiolabeling & In Vivo ADME / PK Contracted Studies

We offer a full suite of in vivo (‘in animal’) ADME (absorption, distribution, metabolism, and excretion) and PK (pharmacokinetic) services, featuring an in vivo team with over 50 years of experience. Our partners in ADME, the Drug Development Solutions Center, specializes in using radiolabeled compounds and safe, ethical practices in animal studies for a drug’s nonclinical development pipeline.

The Drug Development Solutions Center (DDSC), maintains an AAALAC International-accredited facility with clean rooms for cell culture, an animal care vivarium, and a large variety of instrumentation to perform both radiolabeled and unlabeled IND-enabling (Investigational New Drug application) studies to support your compound’s development. Performing radiolabeled compound synthesis at an early stage allows drug developers to make informed decisions about committing resources to the development of a chemical entity for commercial application, thereby reducing financial risk.

In Vivo Services We Offer

Our Radioisotope (RI) Labeling capabilities allow synthesis of a drug compound with radioisotope ‘tag’ attachment at a metabolically stable site on the investigational drug used in nonclinical and clinical drug development.

Tissue Distribution studies include QWBA, tissue dissection and microautoradiography  methods using qualitative or quantitative detection of radiolabeled compound to elucidate drug accumulation in tissue at successive time points in whole-body or organ-specific sections of a toxicologically-relevant animal species.

Met ID (Metabolite Identification) studies are used to determine how many/which metabolites are formed and the percent of parent exposure (AUC), which complement in vitro species comparison data to determine whether human-specific metabolites are formed through the metabolism of a drug.

Excretion studies, including mass balance and biliary excretion, analyze radiolabeled compounds in urine, feces, expired air, and carcass in toxicologically-relevant species to characterize a drug’s excretion path and rate.

Pharmacokinetic (PK) studies provide exposure (AUC) data by measuring radiolabeled or non-labeled compound presence in plasma from treated laboratory animals; ‘hot’ (radiolabeled) studies can yield more complete information than cold studies by including metabolite concentration in a toxicologically-relevant preclinical species.

In Vivo Plasma Protein Binding studies measure free drug concentration (unbound to proteins) in plasma of toxicologically-relevant species following administration of radiolabeled or unlabeled drug compound.

Our Approach to In Vivo ADME & PK Preclinical Studies

The Drug Development Solutions Center in Tokai, Japan, gives you a specialty contract research (CRO) option with more than 50 years of experience in radiolabeled ADME studies and facility accreditation to meet regulatory standards for regulatory nonclinical data submission. Through our partnership, each in vivo contracted study is planned and managed with the assistance of our SEKISUI XenoTech team, known for excellent customer support and study management experience. 

We pride ourselves on short turnaround time and competitive pricing, even when distance presents a challenge.  

Shipping and handling radioactive materials between countries can be difficult, especially considering the purity that must be validated and maintained to assure quality results, but our experienced team has a thorough understanding of Japanese customs regulations, and will facilitate fast, safe and careful transport of materials to ensure clients’ compounds are protected.

The level of expertise held by the Drug Development Solutions Center team translates to more efficiency in processes to radiolabel compounds, and because pricing of radiochemical services is informed in large part by steps in these processes, saving you money and time. Read more in our blog about how we make it easy to work with the Drug Development Solutions Center for your in vivo nonclinical services.

Our sister laboratory, the Drug Development Solutions center in Tokai, Japan is the number one ADME CRO in Japan.

Regulatory Compliance

Studies conducted at Drug Development Solutions Center also meet or exceed standards required by regulatory authorities, including FDA and EMA, just as with our Kansas City campus. While in the United States, there is no method by which an institution can claim certified compliance with Good Laboratory Practice (GLP) standards, the PMDA can grant certification following an inspection that approves a Japanese facility as GLP-compliant in specific practices. The Drug Development Solutions Center has this certification for all bioanalytical services, a critical component of many animal studies. The Center is also certified by AAALAC International for ethical use of animals in research so you can be sure services exceed quality standards required by the FDA upon IND or NDA submission. 

Which Studies & Why

Not sure which in vivo studies you should plan before your drug goes to first in-human (FIH) clinical trials? Read our quick guide outlining regulatory expectations and basic study outlines for each basic in vivo study we offer

In Vivo ADME and Hepatotoxicity studies

In Vivo ADME Science

Access ADME is your go-to repository for our scientists’ content relevant to radiolabeling and in vivo drug development

In vivo adme rat study