Introduction/Objectives: Tenofovir alafenamide (TAF) is a second generation oral prodrug of tenofovir (TFV), a nucleotide analog that inhibits HIV type…
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Joint mechanistic modeling of viral and antibody responses to vaccines in Non-Human Primates to quantify SARS-CoV-2 mechanistic correlate of protection.
Introduction and objectives: SARS-CoV-2 evolves constantly and rapidly. The identification of correlates of protection (CoPs) against the pathogen could accelerate…
Read moreReconstruction of an Advanced Dissolution, Absorption, and Metabolism (ADAM) Model in R: Structural Comparison with Simcyp and PK-Sim
Objectives: Physiologically based pharmacokinetic (PBPK) models are widely used to characterize oral drug absorption, yet important structural differences exist between…
Read morePHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING OF LOSARTAN FOR THE PREDICTION OF DRUG-DRUG- AND DRUG-GENE-INTERACTIONS
Introduction: According to the World Health Organization, losartan is considered an Essential Medicine and ranks among the ten most frequently…
Read moreImpact of Below Limit of Quantification (BLQ) Concentrations handling strategies on Concentration-QTc analysis
Introduction: The International Council for Harmonisation (ICH) guideline allows for modeling of concentration-QTc (C-QTc) data from Phase I dose-escalation studies…
Read moreThe use of Full Random Effect Models (FREM) in Model Informed Precision Dosing (MIPD) for a priori dose predictions
Introduction: Model-Informed Precision Dosing (MIPD) uses mathematical models to interpret therapeutic drug monitoring samples and predict personalized dosing strategies [1]….
Read morePHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING FOR SUB-SAHARAN AFRICAN POPULATIONS: A REVIEW OF SYSTEM PARAMETERS AND VARIABILITY DRIVERS.
Background. Physiologically based pharmacokinetic (PBPK) models generate exposure predictions from drug-specific parameters interacting with system (population) inputs such as organ…
Read moreAdherence to Ribociclib Treatment: Insights from Population Pharmacokinetic Simulations and Plasma Concentration Measurements
Objectives: Ribociclib, a cyclin-dependent kinase 4/6 inhibitor, is an established therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative…
Read moreA MINIMAL MECHANISTIC QSP-READY MODEL TO BRIDGE AGGREPHAGY AND MTOR SIGNALING IN ALS
Introduction: Amyotrophic lateral sclerosis (ALS) is a multifactorial neurodegenerative disease marked by motoneuron loss and progressive muscle atrophy. Familial ALS…
Read moreA FAIR combination: guiding development of a novel immunomodulatory-antibiotic combination therapy using an integrative PKPD framework based on multi-source preclinical data
Introduction: According to recent WHO reports, 17% of bacterial infections worldwide in 2023 were caused by pathogens with antimicrobial resistance…
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