Evidence mapPaperPMID 42212929Full record

ReviewClinical and translational science2026

Human Absorption, Metabolism, and Excretion (hAME) Mass Balance Studies in Patients With Cancer.

Begoña de Las Heras, Claudine Oelke, Pamela Atwell, Hector Herrero, Paulo Nunes, Kamal S Saini, Laura Vidal Boixader, Catherine Laing, James Bush, Emiliano Calvo

Abstract readReview
In one paragraph

Review in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Begoña de Las HerasOncology Consultants, Madrid, Spain.ORCID https://orcid.org/0000-0003-3091-1684
Claudine OelkeFortrea Inc., Durham, North Carolina, USA.ORCID https://orcid.org/0009-0005-9089-8225
Pamela AtwellFortrea Inc., Durham, North Carolina, USA.
Hector HerreroFortrea Inc., Durham, North Carolina, USA.ORCID https://orcid.org/0009-0007-3770-8503
Paulo NunesFortrea Inc., Durham, North Carolina, USA.ORCID https://orcid.org/0000-0002-4314-9230
Kamal S SainiFortrea Inc., Durham, North Carolina, USA.ORCID https://orcid.org/0000-0001-6301-3309
Laura Vidal BoixaderFortrea Inc., Durham, North Carolina, USA.
Catherine LaingFortrea Inc., Durham, North Carolina, USA.ORCID https://orcid.org/0009-0000-1768-1322
James BushFortrea Inc., Durham, North Carolina, USA.ORCID https://orcid.org/0000-0002-6645-7041
Emiliano CalvoDirector, Clinical Research START Madrid-HM CIOCC Unit, Early Phase Clinical Trials and President, START Europe, Madrid, Spain.ORCID https://orcid.org/0000-0003-4921-829X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Radiolabeled mass balance human studies are a critical component of clinical pharmacology programs supporting the development of new investigational drugs. These studies provide information about absorption, metabolism, and excretion (AME) of the parent drug and metabolite(s) in the human body and are normally conducted in healthy volunteers (HVs). However, in some instances, based on the characteristics and toxicity of the molecule, conducting the study in HVs may not be a viable option and therefore cancer patients (CPs) need to be enrolled. Successful navigation of aspects such as pharmacologic characteristics, dose administration, patient clinical status and comorbidities, confinement period, study extension, team training, and requirements of the hospitals/units are essential to successfully deliver radiolabeled mass balance studies in CPs. This article provides an overview of the main aspects that must be taken into consideration to conduct AME studies in CPs.

Indexed as

Antineoplastic AgentsDrugs, InvestigationalNeoplasmsHealthy VolunteersHumansAntineoplastic AgentsDrugs, Investigationaladministrationcancer patientsexcretion (AME)healthy volunteersmass balancemetabolismoncology

Identifiers

PMID42212929
PMCPMC13240045

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.