Kamal Saini, Global Head, Oncology Therapeutic Expertise at Fortrea, shared a post on LinkedIn:
“I am pleased to share our recently published paper ‘Human Absorption, Metabolism, and Excretion (hAME) Mass Balance Studies in Patients With Cancer’.
Radiolabeled human mass balance (hAME) studies represent a critical component of oncology drug development, providing essential insights into the absorption, metabolism, and excretion of investigational therapies. Although these studies have traditionally been conducted in healthy volunteers, the pharmacological and safety characteristics of many oncology compounds necessitate their evaluation directly in patients with cancer.
In this review lead by Begoña de las Heras Garcia, we examine the scientific, operational, and practical considerations associated with the successful conduct of hAME mass balance studies in oncology patients. Topics addressed include study design, radiolabeled dose administration, patient management, site requirements, multidisciplinary collaboration, and regulatory considerations. The paper is intended to provide practical guidance for sponsors, investigators, and clinical research professionals engaged in the development of novel cancer therapies. (PMC)
This publication reflects the collective expertise, commitment, and collaboration of colleagues across academia, clinical research institutions, and industry. I am grateful for the opportunity to have worked alongside such a distinguished team.”
Title: Human Absorption, Metabolism, and Excretion (hAME) Mass Balance Studies in Patients With Cancer
Authors: Begoña de las Heras, Claudine Oelke, Pamela Atwell, Hector Herrero, Paulo Nunes, Kamal S. Saini, Laura Vidal Boixader, Catherine Laing, James Bush, Emiliano Calvo
Read the Full Article.
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