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Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration
Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration
DZIF-10c (BI 767551) is a recombinant human monoclonal antibody of the IgG1 kappa isotype. It acts as a SARS-CoV-2 neutral...
Model-informed approach to estimate treatment effect in placebo-controlled clinical trials using an artificial intelligence-based propensity weighting methodology to account for non-specific responses to treatment
Model-informed approach to estimate treatment effect in placebo-controlled clinical trials using an artificial intelligence-based propensity weighting methodology to account for non-specific responses to treatment
In randomized, placebo controlled clinical trials (RCT) in major depressive disorders (MDD), treatment response (TR) is es...
Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials
Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials
Composite scale data consists of numerous categorical questions/items that are often summed as a total score and are commo...
A PopPBPK-RL approach for precision dosing of benazepril in renal impaired patients
A PopPBPK-RL approach for precision dosing of benazepril in renal impaired patients
Current treatment recommendations mainly rely on rule-based protocols defined from evidence-based clinical guidelines, whi...
QSP modeling of a transiently inactivating antibody-drug conjugate highlights benefit of short antibody half life
QSP modeling of a transiently inactivating antibody-drug conjugate highlights benefit of short antibody half life
Antibody drug conjugates (ADC) are a promising class of oncology therapeutics consisting of an antibody conjugated to a pa...
Novel endpoints based on tumor size ratio to support early clinical decision-making in oncology drug-development
Novel endpoints based on tumor size ratio to support early clinical decision-making in oncology drug-development
In oncology drug development, overall response rate (ORR) is commonly used as an early endpoint to assess the clinical ben...
Translational pharmacokinetic and pharmacodynamic modelling of the anti-ADAMTS-5 NANOBODY (M6495) using the neo-epitope ARGS as a biomarker
Translational pharmacokinetic and pharmacodynamic modelling of the anti-ADAMTS-5 NANOBODY (M6495) using the neo-epitope ARGS as a biomarker
M6495 is a first-in-class NANOBODY® molecule and an inhibitor of ADAMTS-5, with the potential to be a disease modifyi...
Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan
Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan
Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness ...
Do P-glycoprotein-mediated drug-drug interactions at the blood-brain barrier impact morphine brain distribution?
Do P-glycoprotein-mediated drug-drug interactions at the blood-brain barrier impact morphine brain distribution?
P-glycoprotein (P-gp) is a key efflux transporter and may be involved in drug-drug interactions (DDIs) at the blood-brain ...
A physiologically-based quantitative systems pharmacology model for mechanistic understanding of the response to alogliptin and its application in patients with renal impairment
A physiologically-based quantitative systems pharmacology model for mechanistic understanding of the response to alogliptin and its application in patients with renal impairment
Alogliptin is a highly selective inhibitor of dipeptidyl peptidase-4 and primarily excreted as unchanged drug in the urine...
No QT interval prolongation effect of sepiapterin: a concentration-QTc analysis of pooled data from phase 1 and phase 3 studies in healthy volunteers and patients with phenylketonuria
No QT interval prolongation effect of sepiapterin: a concentration-QTc analysis of pooled data from phase 1 and phase 3 studies in healthy volunteers and patients with phenylketonuria
Sepiapterin is an exogenously synthesized new chemical entity that is structurally equivalent to endogenous sepiapterin, a...
Stronger together: a cross-SIG perspective on improving drug development
Stronger together: a cross-SIG perspective on improving drug development
Pharmacometric modeling and simulation (M&S) plays an increasingly important role in drug development. In order to bri...
Quantifying natural amyloid plaque accumulation in the continuum of Alzheimer’s disease using ADNI
Quantifying natural amyloid plaque accumulation in the continuum of Alzheimer’s disease using ADNI
Brain amyloid beta neuritic plaque accumulation is associated with an increased risk of progression to Alzheimer’s d...
Reliability of in vitro data for the mechanistic prediction of brain extracellular fluid pharmacokinetics of P-glycoprotein substrates in vivo; are we scaling correctly?
Reliability of in vitro data for the mechanistic prediction of brain extracellular fluid pharmacokinetics of P-glycoprotein substrates in vivo; are we scaling correctly?
Plasma pharmacokinetic (PK) profiles often do not resemble the PK within the central nervous system (CNS) because of blood...
Defining preclinical efficacy with the DNAPK inhibitor AZD7648 in combination with olaparib: a minimal systems pharmacokinetic–pharmacodynamic model
Defining preclinical efficacy with the DNAPK inhibitor AZD7648 in combination with olaparib: a minimal systems pharmacokinetic–pharmacodynamic model
AZD7648 is a potent inhibitor of DNA-dependent protein kinase (DNA-PK), which is part of the non-homologous end-joining DN...
The impact of misspecified covariate models on inclusion and omission bias when using fixed effects and full random effects models
The impact of misspecified covariate models on inclusion and omission bias when using fixed effects and full random effects models
Identification of covariates that can explain sources of variability among individuals in pharmacometric models is key, as...
Sampling from covariate distribution may not always be necessary in PK/PD simulations: illustrative examples with antibiotics
Sampling from covariate distribution may not always be necessary in PK/PD simulations: illustrative examples with antibiotics
Pharmacokinetics (PK)/pharmacodynamics (PD) modeling and simulation is crucial for optimizing antimicrobial dosing. This s...
Imputation of missing clock times – application to procalcitonin concentration time course after birth
Imputation of missing clock times – application to procalcitonin concentration time course after birth
The time course of biomarkers (e.g., acute phase proteins) are typically described using days relative to events of intere...
Information-theoretic evaluation of covariate distributions models
Information-theoretic evaluation of covariate distributions models
Statistical modelling of covariate distributions allows to generate virtual populations or to impute missing values in a c...
Advancing inclusive healthcare through PBPK modelling: predicting the impact of CYP genotypes and enzyme ontogenies on infant exposures of venlafaxine and its active metabolite O-desmethylvenlafaxine in lactation
Advancing inclusive healthcare through PBPK modelling: predicting the impact of CYP genotypes and enzyme ontogenies on infant exposures of venlafaxine and its active metabolite O-desmethylvenlafaxine in lactation
About 15–20% of women experience postnatal depression and may seek advice about medication use whilst breastfeeding....
Predicting efficacy assessment of combined treatment of radiotherapy and nivolumab for NSCLC patients through virtual clinical trials using QSP modeling
Predicting efficacy assessment of combined treatment of radiotherapy and nivolumab for NSCLC patients through virtual clinical trials using QSP modeling
Non-Small Cell Lung Cancer (NSCLC) remains one of the main causes of cancer death worldwide. In the urge of finding an eff...
On inductive biases for the robust and interpretable prediction of drug concentrations using deep compartment models
On inductive biases for the robust and interpretable prediction of drug concentrations using deep compartment models
Conventional pharmacokinetic (PK) models contain several useful inductive biases guiding model convergence to more realist...
Note on importance of correct stoichiometric assumptions for modeling of monoclonal antibodies
Note on importance of correct stoichiometric assumptions for modeling of monoclonal antibodies
Pharmacokinetic modeling of monoclonal antibodies (mAbs) with non-linear binding is based on equations of the target-media...
Oral docetaxel plus encequidar – A pharmacokinetic model and evaluation against IV docetaxel
Oral docetaxel plus encequidar – A pharmacokinetic model and evaluation against IV docetaxel
The development of optimized dosing regimens plays a crucial role in oncology drug development. This study focused on the ...
Model-based comparison of subcutaneous versus sublingual apomorphine administration in the treatment of motor fluctuations in Parkinson’s disease
Model-based comparison of subcutaneous versus sublingual apomorphine administration in the treatment of motor fluctuations in Parkinson’s disease
The objective of this study was to compare the effectiveness of subcutaneous (SC) and sublingual (SL) formulations of apom...
General quasi-equilibrium multivalent binding model to study diverse and complex drug-receptor interactions of biologics
General quasi-equilibrium multivalent binding model to study diverse and complex drug-receptor interactions of biologics
Pharmacokinetics and pharmacodynamics of many biologics are influenced by their complex binding to biological receptors. B...
Visual predictive check of longitudinal models and dropout
Visual predictive check of longitudinal models and dropout
Visual predictive checks (VPC) are commonly used to evaluate pharmacometrics models. However their performance may be hamp...
A review of the physiological effects of microgravity and innovative formulation for space travelers
A review of the physiological effects of microgravity and innovative formulation for space travelers
During the space travel mission, astronauts’ physiological and psychological behavior will alter, and they will star...
Generative models for synthetic data generation: application to pharmacokinetic/pharmacodynamic data
Generative models for synthetic data generation: application to pharmacokinetic/pharmacodynamic data
The generation of synthetic patient data that reflect the statistical properties of real data plays a fundamental role in ...
Population pharmacokinetics and exposure–response relationships of maribavir in transplant recipients with cytomegalovirus infection
Population pharmacokinetics and exposure–response relationships of maribavir in transplant recipients with cytomegalovirus infection
Maribavir is approved for management of post-transplant cytomegalovirus (CMV) infections refractory and/or resistant to CM...
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