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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...
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...
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...
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 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....
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...
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...
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...
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...
Low-dimensional neural ODEs and their application in pharmacokinetics
Low-dimensional neural ODEs and their application in pharmacokinetics
Machine Learning (ML) is a fast-evolving field, integrated in many of today’s scientific disciplines. With the recen...
Prospective approaches to gene therapy computational modeling – spotlight on viral gene therapy
Prospective approaches to gene therapy computational modeling – spotlight on viral gene therapy
Clinical studies have found there still exists a lack of gene therapy dose-toxicity and dose-efficacy data that causes gen...
Towards a platform quantitative systems pharmacology (QSP) model for preclinical to clinical translation of antibody drug conjugates (ADCs)
Towards a platform quantitative systems pharmacology (QSP) model for preclinical to clinical translation of antibody drug conjugates (ADCs)
A next generation multiscale quantitative systems pharmacology (QSP) model for antibody drug conjugates (ADCs) is presente...
Correction to: Training the next generation of pharmacometric modelers: a multisector perspective
Correction to: Training the next generation of pharmacometric modelers: a multisector perspective
Astellas, Northbrook, IL, USAPeter L. BonateAridhia Bioinformatics, Glasgow, Scotland, UKJeffrey S. BarrettMerck & Co....
Physiologically based pharmacokinetic model to predict drug–drug interactions with the antibody–drug conjugate enfortumab vedotin
Physiologically based pharmacokinetic model to predict drug–drug interactions with the antibody–drug conjugate enfortumab vedotin
Enfortumab vedotin is an antibody–drug conjugate (ADC) comprised of a Nectin-4–directed antibody and monomethy...
Training the next generation of pharmacometric modelers: a multisector perspective
Training the next generation of pharmacometric modelers: a multisector perspective
The current demand for pharmacometricians outmatches the supply provided by academic institutions and considerable investm...
Population pharmacokinetic/pharmacodynamic modeling of nifekalant injection with varies dosing plan in Chinese volunteers: a randomized, blind, placebo-controlled study
Population pharmacokinetic/pharmacodynamic modeling of nifekalant injection with varies dosing plan in Chinese volunteers: a randomized, blind, placebo-controlled study
Nifekalant hydrochloride is a class III antiarrhythmic agent which could increase the duration of the action potential and...
Translational physiologically-based pharmacokinetic model for ocular disposition of monoclonal antibodies
Translational physiologically-based pharmacokinetic model for ocular disposition of monoclonal antibodies
We have previously published a PBPK model comprising the ocular compartment to characterize the disposition of monoclonal ...
Optimal sample selection applied to information rich, dense data
Optimal sample selection applied to information rich, dense data
Dense data can be classified into superdense information-poor data (type 1 dense data) and dense information-rich data (ty...
Population pharmacokinetic modeling and dosing simulation of avalglucosidase alfa for selecting alternative dosing regimen in pediatric patients with late-onset pompe disease
Population pharmacokinetic modeling and dosing simulation of avalglucosidase alfa for selecting alternative dosing regimen in pediatric patients with late-onset pompe disease
Avalglucosidase alfa (AVAL) was approved in the United States (2021) for patients with late-onset Pompe disease (LOPD), ag...
Computational neurosciences and quantitative systems pharmacology: a powerful combination for supporting drug development in neurodegenerative diseases
Computational neurosciences and quantitative systems pharmacology: a powerful combination for supporting drug development in neurodegenerative diseases
Successful clinical development of new therapeutic interventions is notoriously difficult, especially in neurodegenerative...
Correction to: Classical structural identifiability methodology applied to low-dimensional dynamic systems in receptor theory
Correction to: Classical structural identifiability methodology applied to low-dimensional dynamic systems in receptor theory
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which...
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