CPT-Pharmacometrics & Systems Pharmacology

Papers
(The TQCC of CPT-Pharmacometrics & Systems Pharmacology is 5. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2021-02-01 to 2025-02-01.)
ArticleCitations
Characterizing the exposure–response relationship of idecabtagene vicleucel in patients with relapsed/refractory multiple myeloma66
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report42
Tumor growth inhibition modeling of individual lesion dynamics and interorgan variability in HER2‐negative breast cancer patients treated with docetaxel42
Mechanistic models for hematological toxicities: Small is beautiful34
Quantitative systems pharmacology in neuroscience: Novel methodologies and technologies33
Development and application of a pediatric mechanistic kidney model30
Semimechanistic models to relate noxious stimulation, movement, and pupillary dilation responses in the presence of opioids30
Issue Information30
Model‐informed drug development of voxelotor in sickle cell disease: Exposure‐response analysis to support dosing and confirm mechanism of action30
Issue Information30
gPKPDviz: A flexible R shiny tool for pharmacokinetic/pharmacodynamic simulations using mrgsolve27
Predicting disease activity in patients with multiple sclerosis: An explainable machine‐learning approach in the Mavenclad trials27
Killing a fly with a sledgehammer: Atezolizumab exposure in real‐world lung cancer patients26
Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform24
23
Physiologically‐based pharmacokinetic modeling for primary metabolites of CYP3A and P‐glycoprotein inhibitors in drug–drug interactions: Should we assume the free drug hypothesis?23
23
LaTeX tutorial for the standardization and automation of population analysis reports21
Population PK/PD model of tacrolimus for exploring the relationship between accumulated exposure and quantitative scores in myasthenia gravis patients21
Issue Information21
Power to identify exposure‐response relationships in phase IIa pulmonary tuberculosis trials with multi‐dimensional bacterial load modeling19
Issue Information19
Association between SARS‐CoV‐2 viral kinetics and clinical score evolution in hospitalized patients19
Perspectives on training quantitative systems pharmacologists18
18
Estimating fetal exposure to the P‐gp substrates, corticosteroids, by PBPK modeling to inform prevention of neonatal respiratory distress syndrome18
The Asian Pharmacometrics Network: The historical background, establishment, objectives and roles, and recent activities18
Population pharmacokinetics of ivermectin after mass drug administration in lymphatic filariasis endemic communities of Tanzania17
Step‐by‐step comparison of ordinary differential equation and agent‐based approaches to pharmacokinetic‐pharmacodynamic models17
A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II17
17
Issue Information17
Understanding effect site pharmacology of uprifosbuvir, a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development17
A multistate modeling and simulation framework to learn dose–response of oncology drugs: Application to bintrafusp alfa in non‐small cell lung cancer17
Physiologically‐based pharmacokinetic model of sparsentan to evaluate drug–drug interaction potential16
Physiologically based pharmacokinetic modeling of imatinib and N‐desmethyl imatinib for drug–drug interaction predictions16
Interplay among malnutrition, chemoprevention, and the risk of malaria in young Ugandan children: Longitudinal pharmacodynamic and growth analysis16
PK/PD modeling to characterize placebo and treatment effect of omalizumab for chronic spontaneous urticaria16
Issue Information15
15
PK/PD modeling and simulation of the in vitro activity of the combinations of isavuconazole with echinocandins against Candida auris15
Issue Information15
A tutorial for model‐based evaluation and translation of cardiovascular safety in preclinical trials15
Physiologically based pharmacokinetic modeling for development and applications of a virtual celiac disease population using felodipine as a model drug14
Copanlisib population pharmacokinetics from phase I–III studies and exposure–response relationships in combination with rituximab14
Designing phase I oncology dose escalation using dose–exposure–toxicity models as a complementary approach to model‐based dose–toxicity models14
Mixed effects modeling of radiotherapy in combination with immune checkpoint blockade or inhibitors of theDNAdamage response pathway14
Assessing the predictive performance of population pharmacokinetic models for intravenous polymyxin B in critically ill patients14
Integrating machine learning with pharmacokinetic models: Benefits of scientific machine learning in adding neural networks components to existing PK models14
13
13
Role of pharmacometrics and systems pharmacology in facilitating efficient dose optimization in oncology13
Evaluation of postprandial total triglycerides within the TIGG model for characterizing postprandial response of glucose, insulin, and GLP‐113
Translating in vitro CFTR rescue into small molecule correctors for cystic fibrosis using the Library of Integrated Network‐based Cellular Signatures drug discovery platform13
End‐to‐end application of model‐informed drug development for ertugliflozin, a novel sodium‐glucose cotransporter 2 inhibitor13
13
Artificial intelligence–guided precision treatment of chronic kidney diseasemineral bone disorder12
Disease progression modeling of the North Star Ambulatory Assessment for Duchenne Muscular Dystrophy12
Altered intravenous drug disposition in people living with cystic fibrosis: A meta‐analysis integrating top‐down and bottom‐up data12
Detecting placebo and drug effects on Parkinson's disease symptoms by longitudinal item‐score models12
Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis12
Efficient and relevant stepwise covariate model building for pharmacometrics12
A systematic efficacy analysis of tuberculosis treatment with BPaL‐containing regimens using a multiscale modeling approach12
Construction of a prognostic model based on memory CD4+ T cell–associated genes for lung adenocarcinoma and its applications in immunotherapy11
Exposure–response analysis of efficacy and safety for pexidartinib in patients with tenosynovial giant cell tumor11
Population PK/PD modeling of low‐density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti‐PCSK9 monoclonal antibo11
Issue Information11
Evaluation of covariate effects in item response theory models11
Modeling tumor size dynamics based on real‐world electronic health records and image data in advanced melanoma patients receiving immunotherapy11
Tumor growth inhibition modeling to support the starting dose for dacomitinib11
Deep‐NCA: A deep learning methodology for performing noncompartmental analysis of pharmacokinetic data11
Development of a physiologically‐based pharmacokinetic model for Ritonavir characterizing exposure and drug interaction potential at both acute and steady‐state conditions11
Development and application of neonatal physiology‐based pharmacokinetic models of amikacin and fosfomycin to assess pharmacodynamic target attainment11
Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy11
Synthetic Model Combination: A new machine‐learning method for pharmacometric model ensembling10
Quantitative systems pharmacology model for Alzheimer’s disease to predict the effect of aducanumab on brain amyloid10
Evaluating drug interaction potential from cytokine release syndrome using a physiologically based pharmacokinetic model: A case study of teclistamab10
Physiologically‐based pharmacokinetic modeling of remdesivir and its metabolites in pregnant women with COVID‐1910
Exposure–response modeling for nausea incidence for cotadutide using a Markov modeling approach10
Physiologically‐based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population10
Population pharmacokinetics and exposure–response analyses of polatuzumab vedotin in patients with previously untreated DLBCL from the POLARIX study10
Population PBPK modeling using parametric and nonparametric methods of the Simcyp Simulator, and Bayesian samplers10
A combined physiologically‐based pharmacokinetic and quantitative systems pharmacology model for modeling amyloid aggregation in Alzheimer's disease10
WITHDRAWAL: Quantitative modeling of approved and emerging therapeutics for modifying TTR levels in patients with Transthyretin Amyloid Cardiomyopathy10
Quantification of the effect of GLP1R agonists on body weight using in vitro efficacy information: An extension of the Hall body composition model10
Clinical pharmacokinetics of leriglitazone and a translational approach using PBPK modeling to guide the selection of the starting dose in children10
Concentration‐QTc and cardiac safety analysis of single and multiple zavegepant nasal spray doses in healthy participants to support approval10
Development of a multiscale mechanistic modeling framework integrating differential cellular kinetics of CAR T‐cell subsets and immunophenotypes in cancer patients10
Physiologically‐based pharmacokinetic modeling of prominent oral contraceptive agents and applications in drug–drug interactions10
Population pharmacokinetic analysis for dose regimen optimization of vancomycin in Southern Chinese children10
Hallmarks of neurodegenerative disease: A systems pharmacology perspective9
Mathematical model of the relationship between pH holding time and erosive esophagitis healing rates9
Easy and reliable maximum a posteriori Bayesian estimation of pharmacokinetic parameters with the open‐source R package mapbayr9
Dose optimization of cefazolin in South African children undergoing cardiac surgery with cardiopulmonary bypass9
Bayesian sparse regression for exposure–response analyses of efficacy and safety endpoints to justify the clinical dose of valemetostat for adult T‐cell leukemia/lymphoma9
Applying interpretable machine learning workflow to evaluate exposure–response relationships for large‐molecule oncology drugs9
Pharmacometric and statistical considerations for dose optimization9
Precision dosing of intravenous busulfan in pediatric hematopoietic stem cell transplantation: Results from a multicenter population pharmacokinetic study9
Model‐based meta‐analysis of non‐small cell lung cancer with standard of care PD‐1 inhibitors and chemotherapy for early development decision making9
A quantitative systems pharmacology approach to support mRNA vaccine development and optimization8
Correction to “Physiologically‐based pharmacokinetic pharmacodynamic parent‐metabolite model of edoxaban to predict drug–drug‐disease interactions: M4 contribution”8
Deep compartment models: A deep learning approach for the reliable prediction of time‐series data in pharmacokinetic modeling8
Mechanistic modeling of generic orally inhaled drug products: A workshop summary report8
SAMBA: A novel method for fast automatic model building in nonlinear mixed‐effects models8
Correction to Network module‐based drug repositioning for pulmonary arterial hypertension8
Interim analysis, a tool to enhance efficiency of pharmacokinetic studies: Pharmacokinetics of rifampicin in lactating mother–infant pairs8
Development of a physiologically based pharmacokinetic model of fostemsavir and its pivotal application to support dosing in pregnancy8
Model‐based simulation to support the approval of isatuximab alone or with dexamethasone for the treatment of relapsed/refractory multiple myeloma in Japanese patients8
Prediction of the drug–drug interaction potential of the α1‐acid glycoprotein bound, CYP3A4/CYP2C9 metabolized oncology drug, erdafitinib8
Dose/exposure–response modeling in dose titration trials: Overcoming the titration paradox8
Identification of high‐dimensional omics‐derived predictors for tumor growth dynamics using machine learning and pharmacometric modeling8
A minimal physiologically‐based pharmacokinetic modeling platform to predict intratumor exposure and receptor occupancy of an anti‐LAG‐3 monoclonal antibody8
Recent applications of pharmacometrics and systems pharmacology approaches to improve and optimize drug therapy for pregnant and lactating women8
Network module‐based drug repositioning for pulmonary arterial hypertension8
8
Correction to: Simulations to predict clinical trial outcome of bevacizumab plus chemotherapy vs. chemotherapy alone in patients with first‐line gastric cancer and elevated plasma VEGF‐A8
A novel integrated QSP model of in vivo human glucose regulation to support the development of a glucagon/GLP‐1 dual agonist8
Prediction of cytochromes P450 3A and 2C19 modulation by both inflammation and drug interactions using physiologically based pharmacokinetics8
Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations8
Exploration of the potential impact of batch‐to‐batch variability on the establishment of pharmacokinetic bioequivalence for inhalation powder drug products8
Issue Information8
Response to ‘Modeling is data driven: Use it for successful virtual patient generation’7
Moving the needle for oncology dose optimization: A call for action7
A bootstrapping method to optimize go/no‐go decisions from single‐arm, signal‐finding studies in oncology7
Population pharmacokinetic‐pharmacodynamic modeling of clopidogrel for dose regimen optimization based on CYP2C19 phenotypes: A proof of concept study7
Mechanistic modeling of drug products applied to the skin: A workshop summary report7
Reproducing prolonged time to peak bisoprolol concentration by PBPK modeling with lysosomal trapping in enterocytes7
Development of a PBPK model to quantitatively understand absorption and disposition mechanism and support future clinical trials for PB‐2017
A multistate platform model for time‐to‐event endpoints in oncology clinical trials7
Cluster Gauss‐Newton method for a quick approximation of profile likelihood: With application to physiologically‐based pharmacokinetic models7
Covariate analysis of tusamitamab ravtansine, a DM4 anti‐CEACAM5 antibody‐drug conjugate, based on first‐in‐human study7
Physiologically‐based pharmacokinetic modeling of quinidine to establish a CYP3A4, P‐gp, and CYP2D6 drug–drug–gene interaction network7
Quantitative evaluation of trastuzumab deruxtecan pharmacokinetics and pharmacodynamics in mouse models of varying degrees of HER2 expression7
Can a propensity score matching method be applied to assessing efficacy from single‐arm proof‐of‐concept trials in oncology?7
Tutorial on model selection and validation of model input into precision dosing software for model‐informed precision dosing7
A mechanistic modeling platform of SGLT2 inhibition: Implications for type 1 diabetes7
Physiologically‐based pharmacokinetic modeling of oxcarbazepine and levetiracetam during adjunctive antiepileptic therapy in children and adolescents7
Population pharmacokinetic‐pharmacodynamic modeling of serum biomarkers as predictors of tumor dynamics following lenvatinib treatment in patients with radioiodine‐refractory differentiated thyroid ca7
Disease progression joint model predicts time to type 1 diabetes onset: Optimizing future type 1 diabetes prevention studies7
Population pharmacokinetic analysis of ulotaront in subjects with schizophrenia7
A population pharmacokinetic‐pharmacodynamic model of YH12852, a highly selective 5‐hydroxytryptamine 4 receptor agonist, in healthy subjects and patients with functional constipation7
Data‐driven personalization of a physiologically based pharmacokinetic model for caffeine: A systematic assessment7
Rituximab pharmacokinetic and pharmacokinetic–pharmacodynamic evaluation based on a study in diffuse large B‐cell lymphoma: Influence of tumor size on pharmacokinetic and assessment of pharmacokinetic6
Population pharmacokinetics of molnupiravir in adults with COVID‐19: Lack of clinically important exposure variation across individuals6
Issue Information6
Use of physiologically‐based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended‐release nifedipine6
Issue Information6
A physiologically‐based pharmacokinetic model for tuberculosis drug disposition at extrapulmonary sites6
Virtual clinical trials: A tool for predicting patients who may benefit from treatment beyond progression with pembrolizumab in non‐small cell lung cancer6
Issue Information6
6
A pharmacokinetic–pharmacodynamic model for chemoprotective agents against malaria6
Interspecies and in vitro‐in vivo scaling for quantitative modeling of whole‐body drug pharmacokinetics in patients: Application to the anticancer drug oxaliplatin6
Population pharmacokinetic–pharmacodynamic modeling of PB2452, a monoclonal antibody fragment being developed as a ticagrelor reversal agent, in healthy volunteers6
Issue Information6
Model‐informed drug development of voxelotor in sickle cell disease: Population pharmacokinetics in whole blood and plasma6
Cell‐level systems biology model to study inflammatory bowel diseases and their treatment options6
6
Delineating gene–environment effects using virtual twins of patients treated with clozapine6
Issue Information6
Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate6
6
A dynamic model of the intestinal epithelium integrates multiple sources of preclinical data and enables clinical translation of drug‐induced toxicity6
Is PBPK useful to inform product label on managing clinically significant drug interactions mediated by cytokine release syndrome?6
Population pharmacokinetics of adebrelimab – Support of alternative flat dose regimen in extensive‐stage small‐cell lung cancer6
Model‐informed pediatric dose selection of marzeptacog alfa (activated): An exposure matching strategy6
Response to “mixed‐effects models and the drug titration paradox”6
Evaluating the performance of machine‐learning regression models for pharmacokinetic drug–drug interactions6
Exposure–response analysis of adverse events associated with molibresib and its active metabolites in patients with solid tumors6
Update to improve reproducibility and interpretability: A response to “Machine Learning for Tumor Growth Inhibition”6
A multi‐model approach to predict efficacious clinical dose for an anti‐TGF‐β antibody (GC2008) in the treatment of osteogenesis imperfecta6
Case–control matching‐guided exposure‐efficacy relationship for avelumab in patients with urothelial carcinoma6
6
Nonparametric goodness‐of‐fit testing for parametric covariate models in pharmacometric analyses6
Issue Information6
A physiologically‐based pharmacokinetic precision dosing approach to manage dasatinib drug–drug interactions6
Issue Information6
Physiologically based pharmacokinetic modeling for dose optimization of quinine–phenobarbital coadministration in patients with cerebral malaria6
Establishing a physiologically based pharmacokinetic framework for aldehyde oxidase and dual aldehyde oxidase‐CYP substrates5
Comprehensive Parent‐Metabolite PBPK/PD Modeling Insights Into Methotrexate Personalized Dosing Strategies in Patients With Rheumatoid Arthritis5
Population pharmacokinetics of the GIP/GLP receptor agonist tirzepatide5
Physiologically‐based pharmacokinetic modeling of the drug–drug interaction between ivacaftor and lefamulin in cystic fibrosis patients5
Abstracts5
Physiologically based pharmacokinetic modeling of tacrolimus for food–drug and CYP3A drug–drug–gene interaction predictions5
Potassium homeostasis and therapeutic intervention with sodium zirconium cyclosilicate: A model‐informed drug development case study5
Population pharmacokinetic model with time‐varying clearance for lorlatinib using pooled data from patients with non‐small cell lung cancer and healthy participants5
Investigation of simplified physiologically‐based pharmacokinetic models in rat and human5
Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC‐92480), a novel cereblon E3 ligase modulator5
Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report5
The population pharmacokinetics of dolutegravir co‐administered with rifampicin in Thai people living with HIV: Assessment of alternative dosing regimens5
In silico trial for the assessment of givinostat dose adjustment rules based on the management of key hematological parameters in polycythemia vera patients5
Model‐informed drug development supporting the approval of the avelumab flat‐dose regimen in patients with advanced renal cell carcinoma5
Combining pharmacometric models with predictive and prognostic biomarkers for precision therapy in Crohn's disease: A case study of brazikumab5
Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework5
Issue Information5
5
Building an adaptive dose simulation framework to aid dose and schedule selection5
Population Pharmacokinetics and Pharmacodynamics of Sotalol Following Expedited Intravenous Loading in Patients With Atrial Arrhythmias5
Cluster Gauss‐Newton method analyses of PBPK model parameter combinations of coproporphyrin‐I based on OATP1B‐mediated rifampicin interaction studies5
Genetic and non‐genetic factors influencing efavirenz population pharmacokinetics among human immunodeficiency virus‐1‐infected children in Ethiopia5
Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility5
0.071413993835449