A Review of Imaging Agent Development
Journal Title: The AAPS Journal - Year 2009, Vol 11, Issue 2
Abstract
This educational review highlights the processes, opportunities, and challenges encountered in the discovery and development of imaging agents, mainly positron emission tomography and single-photon emission computed tomography tracers. While the development of imaging agents parallels the drug development process, unique criteria are needed to identify opportunities for new agents. Imaging agent development has the flexibility to pursue functional or nonfunctional targets as long as they play a role in the specific disease or mechanism of interest and meet imageability requirements. However, their innovation is tempered by relatively small markets for diagnostic imaging agents, intellectual property challenges, radiolabeling constraints, and adequate target concentrations for imaging. At the same time, preclinical imaging is becoming a key translational tool for proof of mechanism and concept studies. Pharmaceutical and imaging industries face a common bottleneck in the form of the limited number of trials one company can possibly perform. However, microdosing and theranostics are evidence that partnerships between pharmaceutical and imaging companies can accelerate clinical translation of tracers and therapeutic interventions. This manuscript will comment on these aspects to provide an educational review of the discovery and development processes for imaging agents.
Authors and Affiliations
Eric D. Agdeppa, Mary E. Spilker
US pharmacopeia council of experts 2005–2010: Work plans, new revision approaches, and other enhancements
The United States Pharmacopeial Convention (the USP Convention), which meets at 5-year intervals, last convened in 2005. At that meeting, the convention membership elected a new Council of Experts for the 2005–20...
Pharmacodynamic parameter estimation: Population size versus number of samples
The purpose of this study was to evaluate the effects of population size, number of samples per individual, and level of interindividual variability (IIV) on the accuracy and precision of pharmacodynamic (PD) parameter e...
Intranasal Delivery of Exendin-4 Confers Neuroprotective Effect Against Cerebral Ischemia in Mice
The online version of this article (doi:10.1208/s12248-015-9854-1) contains supplementary material, which is available to authorized users.
Low molecular weight protamine as nontoxic heparin/low molecular weight heparin antidote (III): Preliminary in vivo evaluation of efficacy and toxicity using a canine model
Approaches to the Development of Human Health Toxicity Values for Active Pharmaceutical Ingredients in the Environment
Management of active pharmaceutical ingredients (API) in the environment is challenging because these substances represent a large and diverse group of compounds. Advanced wastewater treatment technologies that can remov...