Introduction: A rising concern in the treatment of malaria is the development of resistance to the artemisinin combination therapy (ACT),…
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Population pharmacokinetic model of atovaquone in infants to adults
Introduction: The development of resistance to the artemisinin combination therapy (ACT), which is the WHO recommended first line treatment in…
Read morePopulation pharmacokinetics of rifampicin and 25-O-desacetyl-rifampicin in Brazilian patients with pulmonary tuberculosis living or not with HIV.
Introduction: Rifampicin (RIF) is possibly the most important drug among the four first-line anti-tuberculosis drugs (FLATDs). Currently, the World Health…
Read moreDesign of a Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Children Aged 1-11 Years, With Active Eosinophilic Esophagitis
Objectives: Eosinophilic esophagitis (EoE) is a chronic, progressive, type 2 inflammatory disease of the esophagus that substantially impairs quality of…
Read morePhysiologically-based Pharmacokinetics modelling to predict the systemic exposure of medicines in infants via breastmilk: a contribution from the ConcePTION Project.
Objectives: For ethical premises, the voluntary and unnecessary exposure of vulnerable patients, such as lactating women and their breastfed infants,…
Read moreApplication of interspecies PBPK modeling to characterize BBB permeability and assess target site exposure-response using levetiracetam as model drug
Introduction: Adequate delivery of drugs at the central nervous system (CNS) level is a prerequisite for drugs in epilepsy. However,…
Read moreCombining aggregate data and individual patient/subject data in model-based meta-analysis: An illustrative case study of tofacitinib in rheumatoid arthritis patients
Objectives: A conventional model-based meta-analysis (MBMA) integrates aggregate data (AD) from multiple studies and may provide more power to detect…
Read moreRevising the assessment of bioequivalence in the light of finite absorption time (FAT) concept: The axitinib case
Objectives: Pharmacokinetics since its inception (1) in 1953 has been built on the notion of an infinite time for oral…
Read moreThe estimates for the absorption rate constant in pharmacokinetics and pharmacometrics are wrong: A new era based on the finite absorption time concept rises
Introduction: Common practice in pharmacokinetic analyses and data evaluation as well as in simulations is based on the assumption that…
Read moreLeveraging the Finite Absorption Time (F.A.T.) Concept for Advancing PBPK Modeling and Pharmacometric structural models: Moving MIDD to Model Informed Drug Development and Assessment (MIDDA)
Introduction: The introduction of the finite absorption time (F.A.T.) concept [1,2] was followed by the development of the pertinent PBFTPK…
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