Objectives: The current WHO guidelines for the treatment of multi-drug-resistant tuberculosis (MDR-TB) recommend that linezolid, an oxazolidinone, is a preferred drug…
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Power to characterize exposure-response relations in phase IIa tuberculosis (TB) trials using bacterial load modeling
Background: A milestone in the development of novel anti-TB drugs is demonstrating the early bactericidal activity (EBA) in a phase…
Read morePopulation pharmacokinetics and exposure-response of BTZ-043 for the treatment of tuberculosis.
Background: Tuberculosis (TB) remains the most deadly infectious disease in the 21st century. Due to lengthy treatment, adverse effects and…
Read moreModel-informed trial design for the malaria transmission blocking antibody TB31F
Introduction: TB31F is a transmission-reducing monoclonal antibody targeting a highly conserved epitope of the malaria gametocyte [1]. A previous study…
Read moreA PKPD model of ribavirin in Lassa virus infected mice
Objectives: Ribavirin is a broad-spectrum antiviral, which is used in the therapy of the Lassa fever. In vitro ribavirin showed…
Read moreHomoarginine population kinetics
Objectives: Homoarginine is an endogenous amino acid. Besides its endogenous synthesis it is a constituent of the human diet. Reduced…
Read morePredictiveness of the human CYP3A4 transgenic mouse model (Cyp3aXAV) for human drug exposure assessed using a population pharmacokinetic approach
Introduction: Approximating the human pharmacokinetic (PK) profile as closely as possible in preclinical settings can still be a struggle in…
Read morePhysiologically based pharmacokinetic model to predict chemotherapy exposure in infants through breastfeeding: paclitaxel as an example
Introduction/Objectives: Little is known about infant safety when breastfed by mothers treated with cytotoxic therapy, with evidence limited to a…
Read moreSAEM in Pumas – A systematic evaluation and benchmarking
Objectives: Stochastic Approximation Expectation Maximization (SAEM) is a robust algorithm for fitting Non-Linear Mixed Effects (NLME) models. Pumas 2.0 introduces SAEM…
Read moreTarget-mediated drug disposition model of rituximab in patients with diffuse large B-cell lymphoma
Objectives: Rituximab is a chimeric anti-CD20 IgG1 monoclonal antibody which specifically binds to the CD20 antigen expressed on the surface of…
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