Posts by tburt
Tal Burt, M.D.
Tal Burt MD is drug development and clinical development consultant. He is the founder and CEO of Burt Consultancy LLC, a drug development consultancy, and of the Phase-0/Microdosing Network, an international consortium of drug development stakeholders invested in increasing the efficiency and productivity of the drug development process through the application of Phase-0 including Microdosing approaches. Dr. Burt is…
Read MorePhase-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…
Read MorePhase-0 Microdosing Definitions
It has been some time since our last discussion of Phase-0 including Microdosing definitions with many new members joining the Network since. This has impact, for example, on the kind of studies that are included in the list of studies shared recently, and of course on the scope of this Network. So here is a recap: Phase-0 Microdosing Definitions By…
Read MorePhase-0/Microdosing: Intra-Target Microdosing (ITM) in actual drug development – recent developments
Dear All, With Intra-Target Microdosing (ITM) a microdose (calculated on a total body basis) is administered locally into a small area of the intended target such that it is sufficient to generate therapeutic-level exposures in the target. For example, if a microdose that is 1/100th of the therapeutic-level dose is administered into the radial artery, the hand,…
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