Posts by talburtmd
Phase-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…
Read MorePhase-0/Microdosing: Intra-Target Microdosing (ITM) in actual drug development – recent developments
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,…
Read MorePhase-0/Microdosing: Wong Estimation of Clinical Trial Success Rates 2019 and the importance of early first-in-patient studies
Wong, C. H., Siah, K. W. & Lo, A. W. Estimation of clinical trial success rates and related parameters. Biostatistics (Oxford, England) 20, 273-286, (2019) Wong et al. from MIT used the largest database to date, 185,994 unique trials and 21,143 compounds, developed between 2000 and 2016 to estimate the productivity of clinical development and…
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