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Length 100 pages
Date published May 2006
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Microdosing in Translational Medicine:
Pros and Cons
Hermann A.M. Mucke, Ph.D.
New Page 1
Figure
1.1: Conventional and Microdosing Approach to Drug Candidate Selection
Figure 2.1: Survey Results: Strong Kinetics Predicability in Human
Microdosing.
Figure 2.2: Pharmacokinetics of Vitamin B12 in Human Plasma Following
Administration of
a 1.5 µg Dose.
Figure 2.3: Layout of a Tandem Accelerator Mass Spectrometer
Figure 2.4: The Principle of Positron-Electron Annihilation
Figure 3.1: Survey Results: Microdosing Studies in 2005
Figure 3.2: Survey Results: Microdosing Studies in 2006 and Beyond
Figure 5.1: Dose-Normalized Concentration-Versus-Time Graphs for
Intravenous Microdose
(0.1 mg) and Intravenous Therapeutic Dose of
Diazepam
Figure 5.2: Dose-Normalized Concentration-Versus-Time Graphs for
Oral Microdose and
Oral Therapeutic Dose of Midazolam
Figure 5.3: Dose-Normalized Concentration-Versus-Time Graphs for
Oral Microdose and
Oral Therapeutic Dose of Warfarin
Figure 5.4: Plasma Concentrations of Investigational Renin Inhibitor
SPP601 after Oral Microdosing of 0.1 mg
Figure 5.5: Projected Time Frame for Microdosing Integration
Figure 6.1: Survey Results: Industry Specialists See Strong Microdosing
Future
Table 4.1: Itemized Comparison of Typical Chemistry, Manufacture
and Control (CMC)
Costs and Timelines in Preparation of Conventional
Phase I and Microdosing Trials
Table 4.2: Upsides and Downsides of Microdosing vs. Conventional
Pathway to First-Time-
in-Human Milestone
Table 5.1: Summary of the CREAM Trial Results Source: Xceleron, Modified
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