Human ADME Studies: Human Metabolism Data For Regulatory Submission

To secure regulatory submission, drug development programs require comprehensive human metabolism data. Quotient Sciences is a leading provider of human ADME (Absorption, Distribution, Metabolism, and Excretion) studies, leveraging over 30 years of experience and more than 300 completed studies.

Quotient Sciences streamlines the human ADME process with their Synthesis-to-Clinic integrated studies, applying their Translational Pharmaceutics approach. This integrated program manages the entire process—from the radiosynthesis of the 14C-labeled drug substance to the clinical testing and final report—providing a cohesive and expedited route to meeting New Drug Application (NDA) requirements or running parallel to proof-of-concept studies.

The integrated approach encompasses all stages, including 14C API synthesis, preclinical data review, regulatory affairs, 14C drug product manufacturing, clinical conduct, and mass balance/metabolite identification. Capabilities include real-time GMP manufacture of 14C drug products for immediate dosing, a dedicated ADME ward, and cutting-edge metabolite profiling and identification instrumentation to deliver rapid mass balance data.

Want to see how an integrated approach can accelerate your program?