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- W2912297460 abstract "This chapter intends to capture the evolution of first-in-human (FIH) starting dose selection approaches of immunomodulatory protein therapeutics (IMPTs) over the past decade and to review the principles and procedures of more integrated pharmacology- and mechanism-based methods for the minimal anticipated biological effect level determination, along with several case studies. An integrated approach including all nonclinical pharmacology data (e.g. human in vitro data) together with the toxicology data is needed to provide a full assessment of the safety risk and provide a more mechanism-based FIH safety starting dose. The chapter also discusses the limitations of the toxicology study in selecting FIH starting dose and a better and more integrated approach in detail. It modifies the integrated starting dose selection scheme by Muller et al. incorporating the in vitro cytokine release assay and other in vitro toxicity assessments as important components for the safety assessment in addition to the in vivo toxicology-based approach." @default.
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- W2912297460 date "2019-02-15" @default.
- W2912297460 modified "2023-09-25" @default.
- W2912297460 title "Application of Minimal Anticipated Biological Effect Level (MABEL) in Human Starting Dose Selection for Immunomodulatory Protein Therapeutics - Principles and Case Studies" @default.
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- W2912297460 doi "https://doi.org/10.1002/9781119289234.ch4" @default.
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