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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...
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...
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...
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...
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...
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...
Recommendations for a standardized publication protocol for a QSP model
Recommendations for a standardized publication protocol for a QSP model
Development of a Quantitative Systems Pharmacology (QSP) model is a long process with many iterative steps. Lack of standa...
Computing optimal drug dosing regarding efficacy and safety: the enhanced OptiDose method in NONMEM
Computing optimal drug dosing regarding efficacy and safety: the enhanced OptiDose method in NONMEM
Recently, an optimal dosing algorithm (OptiDose) was developed to compute the optimal drug doses for any pharmacometrics m...
Population pharmacokinetic analyses of pozelimab in patients with CD55-deficient protein-losing enteropathy (CHAPLE disease)
Population pharmacokinetic analyses of pozelimab in patients with CD55-deficient protein-losing enteropathy (CHAPLE disease)
Pozelimab, a monoclonal antibody directed against C5, is the first and only treatment for adult and pediatric patients (&#...
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...
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 ...
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...
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...
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...
Time Scale Calculus: a new approach to multi-dose pharmacokinetic modeling
Time Scale Calculus: a new approach to multi-dose pharmacokinetic modeling
In this paper, we use Time Scale Calculus (TSC) to formulate and solve pharmacokinetic models exploring multiple dose dyna...
Mixed effect estimation in deep compartment models: Variational methods outperform first-order approximations
Mixed effect estimation in deep compartment models: Variational methods outperform first-order approximations
This work focusses on extending the deep compartment model (DCM) framework to the estimation of mixed-effects. By introduc...
A quantitative modeling framework to understand the physiology of the hypothalamic-pituitary-adrenal axis and interaction with cortisol replacement therapy
A quantitative modeling framework to understand the physiology of the hypothalamic-pituitary-adrenal axis and interaction with cortisol replacement therapy
Congenital adrenal hyperplasia (CAH) is characterized by impaired adrenal cortisol production. Hydrocortisone (synthetic c...
pyDarwin machine learning algorithms application and comparison in nonlinear mixed-effect model selection and optimization
pyDarwin machine learning algorithms application and comparison in nonlinear mixed-effect model selection and optimization
Forward addition/backward elimination (FABE) has been the standard for population pharmacokinetic model selection (PPK) si...
An asymptotic description of a basic FcRn-regulated clearance mechanism and its implications for PBPK modelling of large antibodies
An asymptotic description of a basic FcRn-regulated clearance mechanism and its implications for PBPK modelling of large antibodies
A basic FcRn-regulated clearance mechanism is investigated using the method of matched asymptotic expansions. The broader ...
Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice
Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice
Quantitative predictive modeling of cancer growth, progression, and individual response to therapy is a rapidly growing fi...
Virtual clinical trials via a QSP immuno-oncology model to simulate the response to a conditionally activated PD-L1 targeting antibody in NSCLC
Virtual clinical trials via a QSP immuno-oncology model to simulate the response to a conditionally activated PD-L1 targeting antibody in NSCLC
Recently, immunotherapies for antitumoral response have adopted conditionally activated molecules with the objective of re...
A quantitative systems pharmacology model of plasma kallikrein-kinin system dysregulation in hereditary angioedema
A quantitative systems pharmacology model of plasma kallikrein-kinin system dysregulation in hereditary angioedema
Hereditary angioedema (HAE) due to C1-inhibitor deficiency is a rare, debilitating, genetic disorder characterized by recu...
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...
Translational two-pore PBPK model to characterize whole-body disposition of different-size endogenous and exogenous proteins
Translational two-pore PBPK model to characterize whole-body disposition of different-size endogenous and exogenous proteins
Two-pore physiologically based pharmacokinetic (PBPK) modeling has demonstrated its potential in describing the pharmacoki...
Evaluation of ChatGPT and Gemini large language models for pharmacometrics with NONMEM
Evaluation of ChatGPT and Gemini large language models for pharmacometrics with NONMEM
To assess ChatGPT 4.0 (ChatGPT) and Gemini Ultra 1.0 (Gemini) large language models on NONMEM coding tasks relevant to pha...
Target-mediated drug disposition model for drugs with N > 2 binding sites that bind to a target with one binding site
Target-mediated drug disposition model for drugs with N > 2 binding sites that bind to a target with one binding site
The paper extended the TMDD model to drugs with more than two (N > 2) identical binding sites (N-to-one...
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