About this Research Topic

Background

Testing compounds at subtherapeutic doses in human supported by a reduced pre-clinical package to enable early decisions has been utilized for some years. However, while the concept is appealing and has the potential to save animal experiments, facilitate better decisions informed by early human data, obtain data in vulnerable populations, and increase the quality and value of subsequent studies at therapeutic doses, the uptake has been slow.
Can new concepts like intra-target microdosing (ITM), technological developments or the increasing desire to reduce animal testing give additional momentum to this apparently attractive concept?

Potential nonlinearity of PK, exposure too low for observation of effects, lack of time savings to patient trials, lack of experience, a conservative culture, wrong incentives, and regulatory as well as technical hurdles are perceived or real problems preventing scientists to pursue an early microdose study. But the issues that could be addressed such as a need to streamline the drug development process, ethical, financial, and regulatory pressure to reduce animal testing, and limitations of animal data to predict the human situation need solutions.

Intra-target microdosing is a newer concept tested in oncology, respiratory and other contexts with the potential to further increase the scope of microdosing investigations to answer relevant question. A combination of Phase 0 work with physiology-based pharmacokinetic and other modeling, positron emission tomography (PET), microdialysis or other emerging technologies and support by regulatory bodies could help to increase usage and impact.

We are interested in concepts and applications to illustrate and assess the value of Phase 0 studies.
How can intra-target microdosing across a range of targets increase value by achieving locally potential therapeutic concentrations while maintaining systemic microdose safety.
How can the concerns and risks related to non-linear pharmacokinetics be addressed?
Can microdosing help drug development in vulnerable populations?
How were early decisions (e.g., compound selection or discontinuation) successfully informed and what are additional ways to reduce animal testing?
How do technological and regulatory developments (e.g., GMP requirements, support to reduce animal testing) change the landscape?

The editorial team is interested in the following manuscript types: original research, methods, protocols, hypothesis and theory articles, clinical trials, perspectives, data reports, and brief research reports.


Dr H Markus Weiss is employed by Novartis, he is member of the Phase-0/Microdosing Network.

Dr Esther van Duijn is a Senior Scientist at TNO, a not for profit independent research organization. She works at the biomedical AMS facility, supporting microdosing and microtracer studies in drug development with scientific expertise and the analytical technology. She is also board member of the Phase-0/Microdosing Network, an international consortium of experts and other stakeholders interested in Phase-0 approaches.

Prof Yuichi Sugiyama is the professor in Josai International University and is board member of the Phase-0/Microdosing Network, and is the president of Japanese Drug Metabolism Discussion Group and is a member of the International Transporter Consortium.

Keywords: drug discovery and development, Intra-Target Microdosing (ITM), Vulnerable populations, exploratory clinical trials, Phase 0, microdosing, 3R's, modeling and simulations, technology

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