Quantitative Whole Body Autoradiography (QWBA) Studies

QWBA studies are designed to evaluate the time course of elimination for total radioactivity from tissues in animals.

Tissue distribution data obtained from a QWBA study will be utilized to support regulatory submissions, and discovery-stage projects, and to provide dosimetry calculations required by regulatory authorities and institutional review boards prior to the administration of radiolabeled drugs to human research subjects. 

At Frontage, our QWBA Team utilities state-of-the-art instruments and customizes your QWBA studies to meet your specific objectives.

Experience: 

• Over 30 years of experience conducting QWBA & ADME studies 
• Established PFE-Groton QWBA Laboratory in 1992 
• PFE-Groton QWBA Laboratory became the PFE Global QWBA COE in 2005. Appointed as the COE Head. 
• 5-QWBA manuscripts as the primary author 
• Managed QWBA staff and studies including human dosimetry projections at PFE from 1992 through January 2009 
• Managed the PFE Mass Balance Laboratory and staff for 5 Years 
• Senior Study Director at CVD-Madison and managed small and large animal radiolabeled ADME, small and large animal QWBA, radioanalysis of samples for hAME clinical studies, dosimetry projections, small and large animal PK screening, and metabolite characterization studies from February 2009 to March 2020

Human tissue and whole body exposures to [14C] radioactivity can be estimated by direct extrapolation from the QWBA pigmented rat exposure data. This extrapolation presumes that [14C] radioactivity distributes into and is eliminated from tissues in a comparable manner in human subjects and pigmented rats and that the tissue radiation absorbed doses correlate directly to tissue radioactivity concentrations. 

Radiation dosimetry projections are typically based on guidelines and recommendations from the Food and Drug Administration (FDA) Code of Federal Regulations (CFR) and the International Committee on Radiation Protection (ICRP). Radiation dosimetry is also typically based on a 100 μCi dose of radioactivity administered to human adult subjects. 

The Frontage Laboratories QWBA COE typically issues two reports: one report for the QWBA study and a second report for Radiation Dosimetry at no additional cost

Discover the following In Vivo services at Frontage

Pharmacokinetics

Pharmacokinetics studies to investigate new chemical entities.

MIST – Metabolites in Safety Testing

A key component of human risk assessment for drug candidates.

Radiolabeled Studies

QWBA Studies

Evaluating the time course of elimination for total radioactivity from tissues in animals.

Human C14 AME (hAME) Study Services

Full-Service Radiolabeled hAME Studies