Objectives: The aim of the investigation was to develop a drug-disease model with suitable parameterisation for the screening and selection…
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On the 20th anniversary of ‘Nonlinear models for repeated measurement data’: Nonlinear mixed effects modeling 20 years later
On the 20th anniversary of ‘Nonlinear models for repeated measurement data’, Marie Davidian looks both back and ahead on writing…
Read moreOn the 20th anniversary of ‘Nonlinear models for repeated measurement data’: why write a book about PK/PD modeling?
On the 20th anniversary of ‘Nonlinear models for repeated measurement data’, David Giltinan looks both back on the virtually impossible…
Read moreModeling cancer blood biomarker dynamics in relation to tumor growth
Objectives: Cancer biomarkers, such as proteins that are shed (secreted or released) into the bloodstream from a tumor, may be…
Read moreEMA qualification of novel methodologies: are we ready for M&S ?
Objectives: Engage industry, academia and the European Medicines Agency in discussions on how to qualify modelling & simulation (M&S) platforms to…
Read moreTherapeutic antibody concentrations at the biophase
Objective: Concentrations of monoclonal antibodies in the different tissue compartments, vascular, interstitial and cellular, are very heterogeneous [1, 2]. PK measurements…
Read moreThe zebrafish as model for translational systems pharmacology: expanding the allometric scale in vertebrates with five orders of magnitude
Objectives: The objective was to develop a method to quantify pharmacokinetics (PK) in zebrafish larvae. This can improve the increasingly used…
Read moreHow European Regulators are Facilitating the Use of Modelling and Simulation: MSWG History, Activity and Future
Objectives: The Modelling and Simulation Working Group (MSWG) was established in January 2013 to answer EMA’s commitment to increase the…
Read moreA hidden Markov model to assess drug-induced sleep fragmentation
Objectives: Drug-induced sleep fragmentation can cause sleep disturbances either via their intended pharmacological action or as a side effect. The…
Read moreCost minimization of a phase II clinical study
Objectives: The purpose of phase II studies is to provide initial exploration of drug efficacy and safety in the target…
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