Phase-0/Microdosing approaches: time for mainstream application in drug development?

Dear All,

The manuscript ‘Phase 0/microdosing approaches: time for mainstream application in drug development?’ has been published in Nature Reviews Drug Discovery. It focuses on the scientific methods and applications of Phase-0 approaches and is a summary of the state of the art, limitations, and future directions in the field. It also includes a detailed list of all published Phase-0 studies. Since it reflects a work in progress your thoughts and comments are most welcome.

The article and its appendices (table of studies; summary of PBPK and TMDD relevance to Phase-0) would be useful in discussions with your drug development and policy maker colleagues about the utility and limitations of Phase-0 approaches. Please use it to spread the word and invite others to explore this space. If you receive questions about the operational aspects of these approaches such as ethics, regulatory, economics, statistical, and procedural aspects, there is a dedicated manuscript on these topics in the making. And of course, you can always bring these questions to the attention of the group.

Nature Reviews has kindly allowed us to share the full text of the article with Network members and to share the link to the full text with our colleagues. One effective way to spread the word is to add the link to the full text of the article https://rdcu.be/b61rf as well as the link to our Phase-0/Microdosing Network website https://phase-0microdosing.org/ to your e-mail signatures, social media, and websites.

Many thanks to the authors Yuichi Sugiyama, Malcolm Rowland, Wooin Lee, Oliver Langer, Graeme Young, and Hiroyuki Kusuhara for the diligence and hard work put into this manuscript. And many thanks to all of you, through your work and dedication to this topic and through discussions on the network, you have made the progress in the field and this manuscript possible.

Attached is the combined article and supplements file.

Best regards,
Tal
Tal Burt, M.D. | President
Phase-0/Microdosing Network (Phase-0Microdosing.org)
Burt Consultancy, LLC. (talburtmd.com)
New York, NY, USA
tburt at phase-0microdosing.org | orcid.org/0000-0002-5853-6110
linkedin.com/in/tal-burt-m-d-445888104/
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About Phase-0/Microdosing: https://rdcu.be/b61rf
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