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Cross-species translational modelling of targeted therapeutic oligonucleotides using physiologically based pharmacokinetics
Cross-species translational modelling of targeted therapeutic oligonucleotides using physiologically based pharmacokinetics
Oligonucleotide therapeutics hold promise for targeted gene silencing, yet achieving optimal tissue-specific delivery rema...
The dawn of a new era: can machine learning and large language models reshape QSP modeling?
The dawn of a new era: can machine learning and large language models reshape QSP modeling?
Quantitative Systems Pharmacology (QSP) has emerged as a cornerstone of modern drug development, providing a robust framew...
FDA's insights: implementing new strategies for evaluating drug-induced QTc prolongation
FDA's insights: implementing new strategies for evaluating drug-induced QTc prolongation
The questions and answers (Q&A) document for ICH E14/S7B provides the following advancements for QTc assessment: c...
Physiologically-based pharmacokinetic model for predicting drug-drug interactions perpetrated by posaconazole in healthy subjects with normal weight and obesity: Concomitant use and washout
Physiologically-based pharmacokinetic model for predicting drug-drug interactions perpetrated by posaconazole in healthy subjects with normal weight and obesity: Concomitant use and washout
Posaconazole is an effective broad-spectrum triazole antifungal used as prophylaxis or to treat invasive Aspergillus and C...
Identification of oncology pharmacokinetic drivers through in vitro experiments and computational modeling
Identification of oncology pharmacokinetic drivers through in vitro experiments and computational modeling
Drug discovery balances many factors as it identifies compounds for clinical testing, including compound efficacy, safety,...
A semi-mechanistic population pharmacokinetic-pharmacodynamic model to assess downstream drug-target effects on erythropoiesis
A semi-mechanistic population pharmacokinetic-pharmacodynamic model to assess downstream drug-target effects on erythropoiesis
Erythropoiesis is a complex process that results in the production of erythrocytes from hematopoietic stem cells in the bo...
Quantifying clinical and genetic factors influencing rate and severity of autosomal dominant tubulointerstitial kidney disease progression
Quantifying clinical and genetic factors influencing rate and severity of autosomal dominant tubulointerstitial kidney disease progression
Autosomal dominant tubulointerstitial kidney disease (ADTKD), caused by mutations in UMOD and MUC1 genes, leads to tubular...
Practical guide to concentration-QTc modeling: a hands-on tutorial
Practical guide to concentration-QTc modeling: a hands-on tutorial
Concentration-QTc (C-QTc) analysis is a model-based method widely used to assess the impact of drugs on QT interval durati...
Pharmacometrics education for all by overcoming language barriers to enhance global collaboration
Pharmacometrics education for all by overcoming language barriers to enhance global collaboration
Proficiency in English is essential in scientific disciplines; however, it is unevenly distributed globally, creating barr...
genotypes and the trajectory of biomarkers, neuroimaging, and cognitive measures in Alzheimer’s Disease: A mixed-effects disease progression model
genotypes and the trajectory of biomarkers, neuroimaging, and cognitive measures in Alzheimer’s Disease: A mixed-effects disease progression model
The ε4 allele of the apolipoprotein E gene (APOE4) is a major risk factor for developing sporadic Alzheimer’s d...
Concentration-dependent blood binding: assessing implications through physiologically based Pharmacokinetic modeling of tacrolimus as a case example
Concentration-dependent blood binding: assessing implications through physiologically based Pharmacokinetic modeling of tacrolimus as a case example
Concentration-dependent binding to red blood cells is a characteristic of several drugs, complicating the understanding of...
Computational approaches for toxicology and Pharmacokinetic properties prediction
Computational approaches for toxicology and Pharmacokinetic properties prediction
Pharmacokinetics and toxicological studies how the body reacts to a specific administered substance, such as a drug, toxin...
Advancing drug development with “” modeling informed approaches
Advancing drug development with “” modeling informed approaches
Model-informed Drug Development (MIDD) is an essential framework for advancing drug development and supporting regulatory ...
ADPO: automatic-differentiation-assisted parametric optimization
ADPO: automatic-differentiation-assisted parametric optimization
Automatic differentiation (AD), a key method for accurately and efficiently computing derivatives in modern machine learni...
Impact of covariate model building methods on their clinical relevance evaluation in population pharmacokinetic analyses: comparison of the full model, stepwise covariate model (SCM) and SCM+  approaches - further results based on more conventional practices
Impact of covariate model building methods on their clinical relevance evaluation in population pharmacokinetic analyses: comparison of the full model, stepwise covariate model (SCM) and SCM+  approaches - further results based on more conventional practices
Covariate clinical relevance (CCR) is commonly assessed in population pharmacokinetics using forest plots visualizing para...
In memory of Dr. Thomas M. Ludden: a pioneer in pharmacometrics, a mentor to many, and a legacy of compassionate science
In memory of Dr. Thomas M. Ludden: a pioneer in pharmacometrics, a mentor to many, and a legacy of compassionate science
Cite this articleRiley, S., Korth-Bradley, J., Bauer, R.J. et al. In memory of Dr. Thomas M. Ludden: a pioneer in pharmaco...
Multiorgan-on-a-chip for cancer drug pharmacokinetics-pharmacodynamics (PK-PD) modeling and simulations
Multiorgan-on-a-chip for cancer drug pharmacokinetics-pharmacodynamics (PK-PD) modeling and simulations
Cancer is one of the most common and fatal diseases worldwide and kills millions of people every year. Cancer drug resista...
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...
Translational population target binding model for the anti-FcRn fragment antibody efgartigimod
Translational population target binding model for the anti-FcRn fragment antibody efgartigimod
Efgartigimod is a human IgG1 antibody Fc-fragment that lowers IgG levels through blockade of the neonatal Fc receptor (FcR...
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...
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