The Phase-0/Microdosing Network

The Phase-0 Microdosing Network, a non-profit organization, is an international consortium of inter- and cross-disciplinary drug development stakeholders. These stakeholders share interest in the potential of Phase-0 including microdosing approaches to increase the efficiency and productivity of drug development. It was created to share news and ideas relevant to the research and applications of these approaches and increase their impact in drug development. Members include clinicians, scientists, regulators, Pharma, Biotech, CROs, patient advocacy groups and other non-profit organizations with interest in the potential of these applications to provide safer, faster, and cheaper, live human data for drug development decision-making.

The Phase-0 Microdosing Network aims to use the collective inter-disciplinary knowledge and skills to establish a versatile and comprehensive appreciation of the potential of these approaches to address developmental needs. Specifically, the network considers AMS/PET/LC-MS/MS methodologies and the continuum of microdosing and other Phase-0 approaches are complementary, synergistic, and cost-effective investigational tools for first-in-human, including first-in-patient studies. The network welcomes and encourages discussion of the limitations of these approaches, as aims to clarify their role in current and future drug development and identify criteria for their effective application.

Together with APDD (the Japanese Association for Promoting Drug Development at http://www.apdd-jp.org/) the Phase-0 Microdosing Network is organizing the Second International Phase-0/Microdosing Stakeholder Meeting on April 20, 2020, in Tokyo, Japan.

The Phase-0 Microdosing Network was founded in 2012 by Tal Burt, M.D. while at Duke University. The Network twice won awards for inter-disciplinary work, initiated and supported research projects, led to presentations at professional meetings, publications, and dedicated Network meetings.

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