ArticleTranslational and clinical pharmacology2025
Prediction of first-in-human dose for new composition bee venom based on allometric scaling and pharmacokinetic modeling approach.
Article in Translational and clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
- Physiologically Based Pharmacokinetic Modeling to Predict Human Starting Dose and Pharmacokinetics for Rocbrutinib.Clinical and translational science · 2026Article
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7 authors.
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Abstract
Bee venom is a traditional remedy used to treat conditions related to the nervous and musculoskeletal systems, as well as autoimmune diseases. Recently, we developed a new composition bee venom (NCBV), a fortified content of bee venom phospholipase A2 (bvPLA2), which may be effective in the treatment of Alzheimer's disease. NCBV is currently preparing to conduct a phase 1 clinical trial, and this study aimed to predict the first-in-human (FIH) dose using a mechanistic approach. First, animal pharmacokinetic (PK) studies from three different species were explored and integrated to build a PK model using nonlinear mixed-effect modeling. The final models were described by two-compartment model with first order absorption and elimination, and were used to define the PK parameters for each species. To predict human PK parameters, simple, brain weight (BrW) or maximum lifespan potential (MLP) incorporated allometric scaling approaches were used, with the BrW method showing the highest correlation (R
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