Objectives: To assess similarity of tobramycin concentration-time profiles in serum of Phase III product (TIP-PhIII) and the marketed product (TIP-Mkt)….
Read morePoster: New Modelling Approaches
Individualization of fixed-dose combination (FDC) regimens – methodology and application to pediatric tuberculosis
Objectives: To develop a model based methodology to guide design of FDCs and selection of an exposure based dosing regimen…
Read moreTowards assessing therapy failure in HIV disease: estimating in vivo fitness characteristics of viral mutants by an integrated statistical-mechanistic approach
Objectives: Mechanistic viral infection models have long been used to investigate in vivo HIV-1 dynamics [1], while statistical models [2]…
Read moreTranslating physiologically based Parameterization and Inter-Individual Variability into the Analysis of Population Pharmacokinetics
Objectives: Physiologically based pharmacokinetics (PBPK) is a useful tool for predicting the PK of a drug. The physiological and anatomical…
Read moreSecond order Markov modelling of HAMD responses in depression trials
Objectives: Longitudinal models describing the time course of the clinical endpoint in psychiatric trials are usually empirical. Moreover, conditional on…
Read moreSystems Pharmacology of Chain-Terminating Nucleoside Analogs
Objectives: Nucleoside analogs (NAs) are an important drug class for the treatment of viral infections (HBV, HCV, HSV and HIV)…
Read moreDevelopment and evaluation of dynamical whole body Physiologically-based Models of the Circulation and the Renin-Angiotensin-Aldosterone system
Objectives: This work is aimed to develop a whole body physiologically based pharmacokinetic (wb PBPK) model including a dynamic circulation…
Read morePhysiological modeling of inter-individual variability: Combining PBPK modeling and Markov-Chain-Monte-Carlo approaches
Objectives: The assessment of inter-individual variability is a key aspect in physiology-based pharmacokinetic (PBPK) modeling. Physiological differences like age or…
Read moreAn indirect response model with modulated input rate to characterize the dynamics of Aβ-40 in cerebrospinal fluid
Objectives: The improving understanding of the brain pathology dementia has led to several clinical trials with focus upon the dominating…
Read moreA step-wise analysis of multiple biomarkers drives the development of a Semi-Mechanistic Comprehensive Model. Application to modulation of Amyloid-β.
Objectives: Integrating different biomarkers, to model a biological cascade of responses, results in technical challenges in NONMEM. An example of…
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