Objectives: Quantitative Systems Pharmacology (QSP) has been described as the “quantitative analysis of the dynamic interactions between drug(s) and a biological…
Read morePoster: Methodology - Other topics
Steps Towards a Robust Generic Method for Deconvolution Directly on Pharmacokinetic Profiles
Objectives: The objective of the present investigations is to develop a robust generic method for deconvolution directly on pharmacokinetic (PK) profiles….
Read morePopkinR: a suite of Shiny applications focused on the pharmacometrics workflow
Introduction: Pharmacometrics workflow can be defined by a succession of well-defined tasks ranging from exploratory data analysis, modeling (execution, diagnostics,…
Read morePKPD Exploratory Graphics (xGx) Cheat Sheet
Objectives: Checklists are useful tools not only for beginners, but also for experts in any field. As John D. Cook…
Read moreModel-informed development of Mim8 – a novel bispecific antibody for the treatment of haemophilia A
Objectives: Mim8 is a novel, next-generation FVIIIa mimetic bispecific antibody (biAb) in Phase 3 clinical development for subcutaneous treatment of…
Read moreEvaluating phase I studies in small populations when incorporating pharmacokinetic information
Objectives: To highlight the benefits of conducting a sequential adaptive dose-finding clinical trial by adding information given by PK measurements. We…
Read moreIncorporating pharmacokinetic information in phase I studies in small populations
Objectives: To review and extend existing methods which take into account PK measurements in sequential adaptive designs for early dose-finding studies in…
Read moredfpk: an R package for a practical implementation of PK measurements in dose-finding studies
Objectives: Dose-finding, aiming at finding the maximum tolerated dose (MTD), and pharmacokinetics (PK) studies are the first in human studies in…
Read moreDesign of Phase I Studies based on Mechanism of Action of Anti-Diabetic Drugs; Assessing power, precision and accuracy in a simulation study of glucose tolerance tests
Background and Objectives: In anti-diabetic drug development, phase I studies usually involve short-term glucose provocations, e.g. meal tolerance test (MTT)…
Read moreReproducible Analysis Environments for Pharmacometric modelling and simulation.
Objectives: To provide an easily reproducible analytical computing environment for pharmacometric modelling and simulation without compromising the speed with which…
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