ADME In Vivo & PK Studies
In Vivo ADME & PK Contracted Studies
A full suite of in vivo ADME (absorption, distribution, metabolism, and excretion) and PK (pharmacokinetic) services.
Our Approach to In Vivo ADME & PK Preclinical Studies
The Drug Development Solutions Center is a specialty contract research organization (CRO) 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 GainMed 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 customs regulations, and will facilitate fast, safe and careful transport of materials to ensure clients’ compounds are protected.
Available In Vivo Services
Excretion
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.
Met ID
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.
Plasma Protein Binding
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.
Pharmacokinetics
Pharmacokinetic (PK) studies provide exposure (AUC) data by measuring radiolabeled or non-labeled compound presence in plasma; ‘hot’ (radiolabeled) studies can yield more complete information than cold studies by including metabolite concentration in a toxicologically-relevant preclinical species.
Tissue Distribution
Tissue Distribution studies include Quantitative Whole Body Autoradiography (QWBA) and tissue dissection 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 species.
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 in vivo studies. The Center is also certified by AAALAC International so you can be sure services exceed quality standards required by the FDA upon IND or NDA submission.