Clinical trial development of nonproprietary imaging agents

AJ McEwan - The Journal of Nuclear Medicine, 2008 - search.proquest.com
In response to this challenge, in September of this year SNM launched an innovative
process for integrating imaging biomarkers into phase 1, 2, and 3 clinical trials of new …

[CITATION][C] How the biopharmaceutical industry uses molecular imaging

DR Hwang, J Evelhoch - Journal of Nuclear Medicine, 2008 - Soc Nuclear Med
Over the past decade, biomarkers have been recognized as a critical element needed to
improve predictability and efficiency in the process of developing more effective, more …

Barriers to clinical translation with diagnostic drugs

L Josephson, M Rudin - Journal of Nuclear Medicine, 2013 - Soc Nuclear Med
Radioactive imaging agents, like diagnostic drugs generally, undergo a drug development
process that parallels that of therapeutic agents, with similar development times but …

[PDF][PDF] Imaging biomarkers and surrogates: the evolving regulatory lexicon

G Mills - Journal of Nuclear Medicine, 2008 - Soc Nuclear Med
The Critical Path Initiative (CPI) of the US Food and Drug Administration (FDA), initiated in
2004 and updated with a list of opportunities and guidelines, has 2 key premises:(1) imaging …

The cost of developing imaging agents for routine clinical use

AD Nunn - Investigative radiology, 2006 - journals.lww.com
The objective of this study was to estimate the financial cost of developing new imaging
agents for clinical use and to discuss the effects of these costs on the future clinical imaging …

SNMMI Clinical Trials Network research series for technologists: clinical research primer—use of imaging agents in therapeutic drug development and approval

CD Jeffers, C Lawhn-Heath, RI Butterfield… - Journal of Nuclear …, 2022 - Soc Nuclear Med
The process of bringing a new drug to market is complex and has recently necessitated a
new drug-discovery paradigm for the pharmaceutical industry that is both more efficient and …

The uncertain path to the future of imaging biomarkers

AD Nunn - The Quarterly Journal of Nuclear Medicine and …, 2007 - search.proquest.com
The FDA, in particular, has written extensively of its vision of the future where imaging
agents of all types will play a pivotal role in speeding up drug development in early clinical …

Are there lessons to be learned from drug development that will accelerate the use of molecular imaging probes in the clinic?

WC Eckelman, S Rohatagi, KA Krohn… - Nuclear medicine and …, 2005 - Elsevier
This special issue of the journal contains contributions from participants of the third La Jolla
meeting (The Magic Bullet: A Century Later). The goal of this meeting was twofold: to review …

Choosing a single target as a biomarker or therapeutic using radioactive probes

WC Eckelman, DA Mankoff - Nuclear Medicine and Biology, 2015 - Elsevier
There have been many applications of the peaceful use of the atom. Probably none have
been as effective as the radiopharmaceuticals developed to better understand human …

The role of imaging physicians in industry

S Mahmood, SRM de Llano - The Journal of Nuclear Medicine, 2012 - search.proquest.com
In 2011, new nuclear medicine residency program recommendations included an increased
emphasis on molecular imaging in clinical practice, and the American Board of Nuclear …