Radiopharmaceuticals · Human Mass Balance
GMP Expertise for Human Mass Balance (AME) Trials
GMP support for radiolabeled medicines used in Absorption, Metabolism and Excretion studies.
Radiolabeled medicines are essential tools in human Absorption, Metabolism, and Excretion (AME) studies, also known as human mass balance trials. These studies provide critical insights into a drug's pharmacokinetics, metabolite profile, and clearance mechanisms — essential for regulatory approval and clinical development.
With extensive experience in auditing, manufacturing oversight, and quality control, I support pharmaceutical organizations in developing radiolabeled drug substances and products for AME trials, in line with all GMP, ICH, and regulatory standards in the EU and US.
Human Mass Balance and radiolabeling
Radiolabeled compounds — often labeled with carbon-14 (14C) or tritium (3H) — are used in AME studies because they enable precise tracking of the compound and its metabolites, even at extremely low concentrations, using techniques such as Accelerator Mass Spectrometry (AMS) and radio-HPLC.