Journal article
Advancing Novel Molecular Imaging Agents from Preclinical Studies to First-in-Humans Phase I Clinical Trials in AcademiaA Roadmap for Overcoming Perceived Barriers
Abstract
There is a critical need to advance promising novel molecular imaging (MI) agents for cancer from preclinical studies to first-in-humans Phase I clinical trials in order to realize their full potential for cancer detection and for predicting or monitoring response to targeted ("personalized") cancer therapies. Steps to clinical translation include radiopharmaceutical formulation, preclinical pharmacology and toxicology studies, clinical trial …
Authors
Reilly RM; Lam K; Chan C; Levine M
Journal
Bioconjugate Chemistry, Vol. 26, No. 4, pp. 625–632
Publisher
American Chemical Society (ACS)
Publication Date
April 15, 2015
DOI
10.1021/acs.bioconjchem.5b00105
ISSN
1043-1802
Fields of Research (FoR)
Medical Subject Headings (MeSH)
AnimalsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsClinical Trials, Phase I as TopicDrug ApprovalDrug Evaluation, PreclinicalFemaleHumansIndiumMolecular ImagingMolecular Targeted TherapyRadionuclide ImagingRadiopharmaceuticalsReagent Kits, DiagnosticReceptor, ErbB-2Staining and LabelingTrastuzumab