Observed arrival · 2026-10-05
A first-in-human dosing workflow, rebuilt in open-source R
Clinical pharmacologist Zifeng Mai documents a model-informed drug-development workflow for an LNP therapy, from SDTM datasets through dose simulations.
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- Clinical pharmacology and pharmacometrics teams
- Worth noticing
- Browser-generated plots use synthetic parameters and subjects; the page explicitly says no study data appear in its figures.
Field notes
The page describes regression QC against previously delivered datasets and gives examples of problems the checks were meant to catch, including a nominal-time offset and a biomarker unit mismatch. It also says dose records accounted for redosing and lot-specific lipid content. The displayed concentration figures are generated in the browser from synthetic parameters; the page states that they contain no study data.
Observed signals
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○OpenPublic substance visible
✦PrettyNotable craft visible
●ProPolished or operationally mature
◎NicheUnusually specific use
◉HumanPersonal, local, civic, or handmade
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