title: Regulatory aspects of human radiolabeled mass balance studies in oncology: concise review.
abstract: Human radiolabeled mass balance studies are performed to obtain information about the absorption, distribution, metabolism, and excretion of a drug in development. The main goals are to determine the route of elimination and major metabolic pathways. This review provides an overview of the current regulatory guidelines concerning human radiolabeled mass balance studies and discusses scientific trends seen in the last decade with a focus on mass balance studies of anticancer drugs. This paper also provides an overview of mass balance studies of anticancer agents that were executed in the last 10 years.
authors.affiliation: a Department of Pharmacy & Pharmacology , Antoni Van Leeuwenhoek/the Netherlands Cancer Institute and MC Slotervaart , Amsterdam , The Netherlands ;
authors.forename: C M
authors.initials: CM
authors.lastname: Nijenhuis
authors.affiliation: b Department of Medical Oncology, Division of Clinical Pharmacology , The Netherlands Cancer Institute , Amsterdam , The Netherlands ;|c Department of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science , Utrecht University , Utrecht , The Netherlands.
authors.forename: J H M
authors.initials: JH
authors.lastname: Schellens
authors.affiliation: a Department of Pharmacy & Pharmacology , Antoni Van Leeuwenhoek/the Netherlands Cancer Institute and MC Slotervaart , Amsterdam , The Netherlands ;|c Department of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science , Utrecht University , Utrecht , The Netherlands.
authors.forename: J H
authors.initials: JH
authors.lastname: Beijnen
mesh_terms: D016588:Anticarcinogenic Agents / Q000493:pharmacokinetics*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006801:Humans; D008495:Medical Oncology / Q000331:legislation & jurisprudence; D011868:Radioisotopes / Q000493:pharmacokinetics*
chemical_list: D016588:Anticarcinogenic Agents; D011868:Radioisotopes
keywords: Metabolite identification; carbon-14; mass balance studies; pharmacokinetics; radiolabeled drugs; regulatory guidelines; study design