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AAALAC Accredited In Vivo Animal ADME Studies

Animal Excretion Studies to Support Your Drug’s Development

An absorption, distribution, metabolism, and excretion (ADME) study package can be variable depending on a drug candidate’s chemical properties, but a standard in vivo package includes mass balance and biliary excretion studies to determine route and rate of elimination of a parent drug and its metabolites.

Regulatory agencies recommend conducting mass balance studies proactively, i.e., pre-IND, to gather appropriate data to inform study design and dosing considerations for first in-human (FIH) clinical trials. Armed with corroborative in vivo and in vitro data illuminating ADME characteristics of their drug compound, drug developers can move forward from preclinical to clinical development with confidence that they have the information they need to conduct safe, informed clinical trials.

“examining drug parent or metabolites in excreta or biomaterial can help drug developers understand important ADME and PK properties of their drug candidate

In Vivo Excretion Studies We Offer

Nonclinical in vivo Mass Balance studies can provide data to inform the route of elimination and concentrations of total drug-related material urine, feces, and expired air.

Excretion into bile may be investigated via Bile Duct Cannulation (BDC) in a Biliary Excretion study in cases where >20% of radioactivity is detectable in feces during the mass balance study.

Reabsorption through enterohepatic circulation can be investigated if a drug shows extensive excretion into the bile in biliary excretion study.

Other Excretion Route Capabilities

  • Lymphatic Partition rate
  • Excretion into milk 

Our Approach to Preclinical Excretion Studies 

We offer in vivo excretion studies using radiolabeled or unlabeled compound to accurately quantify drug-related material in excreta or bile of treated animals. Our team at the Drug Development Solutions Center in Tokai, Japan, has been working with radiolabeled pharmaceutical compounds and conducting in vivo ADME studies for more than 50 years and in addition to vast experience and training, they carry out all services at a sprawling state-of-the-art AAALAC-accredited facility with capacity to house hundreds of animals and meet strict quality and ethical standards of FDA, EMA, and PMDA regulations. 

Working with the Drug Development Solutions Center

All RI-labeled compound shipping and handling are seamlessly managed by a designated study director or business development representative who will coordinate all communications throughout the process. Working with our team, clients can be confident they will get signature, unparalleled customer service and technical expertise from SEKISUI XenoTech and the Drug Development Solutions Center.

Our team of experts has built a strong reputation for quick response time and dedicated, experienced study directors handling each and every study, whether carried out in Kansas City or Tokai. By contracting a Drug Development Solutions Center study through SEKISUI XenoTech, we make it easy for North American and European clients to benefit from the years of experience our Tokai team has built. 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.

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. 

Related Content:

Data from a rodent mass balance study is used with QWBA distribution data to provide critical exposure inputs for dosimetry calculations, which are required for planning radiolabeled mass balance studies in human absorption, metabolism, and excretion (hAME) studies– find out more about planning your next QWBA study with us.

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

Expert consulting services for gap analysis and more

In Vivo ADME Science

Access ADME™ is your go-to repository for our scientists’ content relevant to radiolabeling and in vivo drug development, including information about regulatory expectations and expertise of our Tokai team

Animal models including rat, mouse, and dog an be used to compare drug metabolism in humans to tox species