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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...
A systematic evaluation of population pharmacokinetic models for polymyxin B in patients with liver and/or kidney dysfunction
A systematic evaluation of population pharmacokinetic models for polymyxin B in patients with liver and/or kidney dysfunction
Polymyxin B (PMB) is considered a last-line treatment for multidrug-resistant (MDR) gram-negative bacterial infections. Mo...
Five multivariate Duchenne muscular dystrophy progression models bridging six-minute walk distance and MRI relaxometry of leg muscles
Five multivariate Duchenne muscular dystrophy progression models bridging six-minute walk distance and MRI relaxometry of leg muscles
The study aimed to provide quantitative information on the utilization of MRI transverse relaxation time constant (MRI-T2)...
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
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
Covariate analysis in population pharmacokinetics is key for adjusting doses for patients. The main objective of this work...
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...
Docetaxel, cyclophosphamide, and epirubicin: application of PBPK modeling to gain new insights for drug-drug interactions
Docetaxel, cyclophosphamide, and epirubicin: application of PBPK modeling to gain new insights for drug-drug interactions
The new adjuvant chemotherapy of docetaxel, epirubicin, and cyclophosphamide has been recommended for treating breast canc...
Longitudinal modeling of efficacy response in patients with lupus nephritis receiving belimumab
Longitudinal modeling of efficacy response in patients with lupus nephritis receiving belimumab
Belimumab was approved for active lupus nephritis (LN) in adults in the European Union and patients ≥ 5 ...
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...
Maximum a posteriori Bayesian methods out-perform non-compartmental analysis for busulfan precision dosing
Maximum a posteriori Bayesian methods out-perform non-compartmental analysis for busulfan precision dosing
Dose personalization improves patient outcomes for many drugs with a narrow therapeutic index and high inter-individuality...
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...
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 ...
An industry perspective on current QSP trends in drug development
An industry perspective on current QSP trends in drug development
2023 marks the 10th anniversary of Natpara’s submission to the US FDA, which led to the first recorded regulatory in...
Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis
Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis
Brepocitinib is an oral selective dual TYK2/JAK1 inhibitor and based on its cytokine inhibition profile is expected to pro...
Fourteenth American Conference on Pharmacometrics (ACoP14) – Innovation and Diversity: Redefining Pharmacometrics
Fourteenth American Conference on Pharmacometrics (ACoP14) – Innovation and Diversity: Redefining Pharmacometrics
The author, serving as the Chair of ACoP14, expresses profound gratitude to the committed members of the ACoP14 Planning C...
A minimal physiologically based pharmacokinetic model to study the combined effect of antibody size, charge, and binding affinity to FcRn/antigen on antibody pharmacokinetics
A minimal physiologically based pharmacokinetic model to study the combined effect of antibody size, charge, and binding affinity to FcRn/antigen on antibody pharmacokinetics
Protein therapeutics have revolutionized the treatment of a wide range of diseases. While they have distinct physicochemic...
Subgroup identification-based model selection to improve the predictive performance of individualized dosing
Subgroup identification-based model selection to improve the predictive performance of individualized dosing
Currently, model-informed precision dosing uses one population pharmacokinetic model that best fits the target population....
Thoughts on plagiarism and the case against Claudine Gay
Thoughts on plagiarism and the case against Claudine Gay
Plagiarism has been all over the news since the end of 2023 when Claudine Gay, Presid...
Population pharmacokinetics of the dual endothelin receptor antagonist aprocitentan in subjects with or without essential or resistant hypertension
Population pharmacokinetics of the dual endothelin receptor antagonist aprocitentan in subjects with or without essential or resistant hypertension
Aprocitentan is a novel, potent, dual endothelin receptor antagonist that recently demonstrated efficacy in the treatment ...
A population pharmacokinetics model of balovaptan to support dose selection in adult and pediatric populations
A population pharmacokinetics model of balovaptan to support dose selection in adult and pediatric populations
Balovaptan is a brain-penetrating vasopressin receptor 1a antagonist previously investigated for the core symptoms of auti...
Correction: External control arms for rare diseases: building a body of supporting evidence
Correction: External control arms for rare diseases: building a body of supporting evidence
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which...
How drug onset rate and duration of action affect drug forgiveness
How drug onset rate and duration of action affect drug forgiveness
Medication nonadherence is one of the largest problems in healthcare today, particularly for patients undergoing long-term...
Semi-mechanistic modeling of resistance development to β-lactam and β-lactamase-inhibitor combinations
Semi-mechanistic modeling of resistance development to β-lactam and β-lactamase-inhibitor combinations
The use of β-lactam (BL) and β-lactamase inhibitor (BLI) combinations, such as piperacillin-tazobactam (PIP-TAZ)...
Comparison of monoclonal antibody disposition predictions using different physiologically based pharmacokinetic modelling platforms
Comparison of monoclonal antibody disposition predictions using different physiologically based pharmacokinetic modelling platforms
Physiologically based pharmacokinetic (PBPK) models can be used to leverage physiological and in vitro data to predict mon...
Population pharmacokinetics and pharmacodynamics of efmarodocokin alfa (IL-22Fc)
Population pharmacokinetics and pharmacodynamics of efmarodocokin alfa (IL-22Fc)
Efmarodocokin alfa (IL-22Fc) is a fusion protein of human IL-22 linked to the crystallizable fragment (Fc) of human IgG4. ...
Learning pharmacometric covariate model structures with symbolic regression networks
Learning pharmacometric covariate model structures with symbolic regression networks
Efficiently finding covariate model structures that minimize the need for random effects to describe pharmacological data ...
Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019–2023) by US FDA, best practices and recommendations
Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019–2023) by US FDA, best practices and recommendations
There are many challenges with rare diseases drug development and rare oncology indications are not different. To understa...
Explaining in-vitro to in-vivo efficacy correlations in oncology pre-clinical development via a semi-mechanistic mathematical model
Explaining in-vitro to in-vivo efficacy correlations in oncology pre-clinical development via a semi-mechanistic mathematical model
In-vitro to in-vivo correlations (IVIVC), relating in-vitro parameters like IC50 to in-vivo drug exposure in plasma and tu...
Characterization of anti-drug antibody dynamics using a bivariate mixed hidden-markov model by nonlinear-mixed effects approach
Characterization of anti-drug antibody dynamics using a bivariate mixed hidden-markov model by nonlinear-mixed effects approach
Biological therapies may act as immunogenic triggers leading to the formation of anti-drug antibodies (ADAs). Population p...
Expansion of platform physiologically-based pharmacokinetic model for monoclonal antibodies towards different preclinical species: cats, sheep, and dogs
Expansion of platform physiologically-based pharmacokinetic model for monoclonal antibodies towards different preclinical species: cats, sheep, and dogs
Monoclonal antibodies (mAbs) are becoming an important therapeutic option in veterinary medicine, and understanding the ph...
Evaluation of prompt engineering strategies for pharmacokinetic data analysis with the ChatGPT large language model
Evaluation of prompt engineering strategies for pharmacokinetic data analysis with the ChatGPT large language model
To systematically assess the ChatGPT large language model on diverse tasks relevant to pharmacokinetic data analysis. Chat...
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