CPT-Pharmacometrics & Systems Pharmacology

Article	Citations
Timing of Antiviral Treatment Initiation is Critical to Reduce SARS‐CoV‐2 Viral Load	132
Data Digitizing: Accurate and Precise Data Extraction for Quantitative Systems Pharmacology and Physiologically‐Based Pharmacokinetic Modeling	53
Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility	47
Mini‐Review: Comprehensive Drug Disposition Knowledge Generated in the Modern Human Radiolabeled ADME Study	36
Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%	35
An artificial neural network−pharmacokinetic model and its interpretation using Shapley additive explanations	34
QSP‐IO: A Quantitative Systems Pharmacology Toolbox for Mechanistic Multiscale Modeling for Immuno‐Oncology Applications	32
Application of Physiologically‐Based Pharmacokinetic Modeling to Predict Gastric pH‐Dependent Drug–Drug Interactions for Weak Base Drugs	25
PK/PD modeling of FXI antisense oligonucleotides to bridge the dose‐FXI activity relation from healthy volunteers to end‐stage renal disease patients	24
Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations	23
A novel method based on unbiased correlations tests for covariate selection in nonlinear mixed effects models: The COSSAC approach	22
Phase II Dose Selection for Alpha Synuclein–Targeting Antibody Cinpanemab (BIIB054) Based on Target Protein Binding Levels in the Brain	22
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration	22
Quantitative prediction of breast cancer resistant protein mediated drug‐drug interactions using physiologically‐based pharmacokinetic modeling	22
Prediction of drug concentrations in milk during breastfeeding, integrating predictive algorithms within a physiologically‐based pharmacokinetic model	22
Guide to development of compound files for PBPK modeling in the Simcyp population‐based simulator	21
PBPK Model of Coproporphyrin I: Evaluation of the Impact of SLCO1B1 Genotype, Ethnicity, and Sex on its Inter‐Individual Variability	21
A mechanism‐based pharmacokinetic model of remdesivir leveraging interspecies scaling to simulate COVID‐19 treatment in humans	20
Opportunities and challenges for applying model‐informed drug development approaches to gene therapies	20
Bench‐to‐bedside translation of chimeric antigen receptor (CAR) T cells using a multiscale systems pharmacokinetic‐pharmacodynamic model: A case study with anti‐BCMA CAR‐T	20
Investigational Treatments for COVID‐19 may Increase Ventricular Arrhythmia Risk Through Drug Interactions	19
PBPK modeling to predict drug‐drug interactions of ivosidenib as a perpetrator in cancer patients and qualification of the Simcyp platform for CYP3A4 induction	19
Mechanistic Models as Framework for Understanding Biomarker Disposition: Prediction of Creatinine‐Drug Interactions	19
A hybrid machine learning/pharmacokinetic approach outperforms maximum a posteriori Bayesian estimation by selectively flattening model priors	19
Exposure–safety analysis of QTc interval and transaminase levels following bedaquiline administration in patients with drug‐resistant tuberculosis	18

Approaches to handling missing or “problematic” pharmacology data: Pharmacokinetics	18
Population pharmacokinetic analysis of ulotaront in subjects with schizophrenia	18
Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges	18
Perspective on model‐informed drug development	18
Reinforcement learning and Bayesian data assimilation for model‐informed precision dosing in oncology	17
Physiologically‐Based Pharmacokinetic Model‐Informed Drug Development for Fenebrutinib: Understanding Complex Drug‐Drug Interactions	17
Modeling Favipiravir Antiviral Efficacy Against Emerging Viruses: From Animal Studies to Clinical Trials	17
Longitudinal Tumor Size and Neutrophil‐to‐Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non‐Small Cell Lung Cancer Treated With Durvalumab	16
Network model‐based screen for FDA‐approved drugs affecting cardiac fibrosis	16
A Prototype QSP Model of the Immune Response to SARS‐CoV‐2 for Community Development	16
Heterogeneous treatment effect analysis based on machine‐learning methodology	16
Prediction of overall survival in patients across solid tumors following atezolizumab treatments: A tumor growth inhibition–overall survival modeling framework	15
A generic framework for the physiologically‐based pharmacokinetic platform qualification of PK‐Sim and its application to predicting cytochrome P450 3A4–mediated drug–drug interactions	15
Brigatinib Dose Rationale in Anaplastic Lymphoma Kinase–Positive Non‐Small Cell Lung Cancer: Exposure–Response Analyses of Pivotal ALTA Study	15
Novel Mechanistic PBPK Model to Predict Renal Clearance in Varying Stages of CKD by Incorporating Tubular Adaptation and Dynamic Passive Reabsorption	15
Physiologically‐Based Pharmacokinetic Modelling of Creatinine‐Drug Interactions in the Chronic Kidney Disease Population	15
Drug‐Disease Interaction and Time‐Dependent Population Pharmacokinetics of Isatuximab in Relapsed/Refractory Multiple Myeloma Patients	15
Comprehensive PBPK model to predict drug interaction potential of Zanubrutinib as a victim or perpetrator	15
Physiologically‐based pharmacokinetic modeling of dextromethorphan to investigate interindividual variability within CYP2D6 activity score groups	15
Application of Machine Learning for Tumor Growth Inhibition – Overall Survival Modeling Platform	15
Physiologically‐based pharmacokinetic modeling to evaluate in vitro‐to‐in vivo extrapolation for intestinal P‐glycoprotein inhibition	14
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities	14
Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate	14
Berkeley Madonna Version 10–A simulation package for solving mathematical models	14
A Quantitative Systems Pharmacology Model of Gaucher Disease Type 1 Provides Mechanistic Insight Into the Response to Substrate Reduction Therapy With Eliglustat	14
A Novel Physiologically Based Model of Creatinine Renal Disposition to Integrate Current Knowledge of Systems Parameters and Clinical Observations	14
Translational pharmacokinetic‐pharmacodynamic modeling of preclinical and clinical data of the oral MET inhibitor tepotinib to determine the recommended phase II dose	14
Evaluation framework for systems models	14
Development of a model‐based clinical trial simulation platform to optimize the design of clinical trials for Duchenne muscular dystrophy	13
Examination of Metoprolol Pharmacokinetics and Pharmacodynamics Across CYP2D6 Genotype‐Derived Activity Scores	13
Hallmarks of neurodegenerative disease: A systems pharmacology perspective	13
Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary	13
Pharmacometric modeling and machine learning analyses of prognostic and predictive factors in the JAVELIN Gastric 100 phase III trial of avelumab	13
Assessing the predictive performance of population pharmacokinetic models for intravenous polymyxin B in critically ill patients	13
Physiologically‐Based Pharmacokinetic Modeling for the Prediction of a Drug–Drug Interaction of Combined Effects on P‐glycoprotein and Cytochrome P450 3A	13
Machine learning algorithms to estimate everolimus exposure trained on simulated and patient pharmacokinetic profiles	13
A Physiologically‐Based Pharmacokinetic Model for the Prediction of “Half‐Life Extension” and “Catch and Release” Monoclonal Antibody Pharmacokinetics	13
Application of quantitative systems pharmacology to guide the optimal dosing of COVID‐19 vaccines	12
Population pharmacokinetics of letermovir following oral and intravenous administration in healthy participants and allogeneic hematopoietic cell transplantation recipients	12
Multistate model for pharmacometric analyses of overall survival in HER2‐negative breast cancer patients treated with docetaxel	12
Model‐Informed Pediatric Dose Selection for Dapagliflozin by Incorporating Developmental Changes	12
Population pharmacokinetics of favipiravir in patients with COVID‐19	12
Data‐driven personalization of a physiologically based pharmacokinetic model for caffeine: A systematic assessment	12
Prediction of CYP‐mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator	12
Population pharmacokinetic modeling of GS‐441524, the active metabolite of remdesivir, in Japanese COVID‐19 patients with renal dysfunction	12
Precision dosing of intravenous busulfan in pediatric hematopoietic stem cell transplantation: Results from a multicenter population pharmacokinetic study	12
Model‐Informed Drug Development for Everolimus Dosing Selection in Pediatric Infant Patients	11
Unraveling pleiotropic effects of rifampicin by using physiologically based pharmacokinetic modeling: Assessing the induction magnitude of P‐glycoprotein–cytochrome P450 3A4 dual substrates	11
Population pharmacokinetic model with time‐varying clearance for lorlatinib using pooled data from patients with non‐small cell lung cancer and healthy participants	11
Introduction of an artificial neural network–based method for concentration‐time predictions	11

Predicting disease activity in patients with multiple sclerosis: An explainable machine‐learning approach in the Mavenclad trials	11
Deep compartment models: A deep learning approach for the reliable prediction of time‐series data in pharmacokinetic modeling	10
Kinetic‐Pharmacodynamic Model of Platelet Time Course in Patients With Moderate‐to‐Severe Atopic Dermatitis Treated With Oral Janus Kinase 1 Inhibitor Abrocitinib	10
Network module‐based drug repositioning for pulmonary arterial hypertension	10
A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development	10
Quantitative systems pharmacology in neuroscience: Novel methodologies and technologies	10
Quantitative Assessment of Levonorgestrel Binding Partner Interplay and Drug‐Drug Interactions Using Physiologically Based Pharmacokinetic Modeling	10
Robust physiologically based pharmacokinetic model of rifampicin for predicting drug–drug interactions via P‐glycoprotein induction and inhibition in the intestine, liver, and kidney	10
Modeling is data driven: Use it for successful virtual patient generation	9
Stable warfarin dose prediction in sub‐Saharan African patients: A machine‐learning approach and external validation of a clinical dose–initiation algorithm	9
Advancing drug safety science by integrating molecular knowledge with post‐marketing adverse event reports	9
Physiologically‐Based Pharmacokinetic Modeling of the Drug–Drug Interaction of the UGT Substrate Ertugliflozin Following Co‐Administration with the UGT Inhibitor Mefenamic Acid	9
Cross‐company collaboration to leverage analytics for clinical quality and accelerate drug development: The IMPALA industry group	9
Cluster Gauss‐Newton method analyses of PBPK model parameter combinations of coproporphyrin‐I based on OATP1B‐mediated rifampicin interaction studies	9
Evaluation of machine learning methods for covariate data imputation in pharmacometrics	9
Quantitative systems pharmacology model for Alzheimer’s disease to predict the effect of aducanumab on brain amyloid	9
Predicting the longitudinal changes of levodopa dose requirements in Parkinson’s disease using item response theory assessment of real‐world Unified Parkinson's Disease Rating Scale	9
Population PBPK modeling using parametric and nonparametric methods of the Simcyp Simulator, and Bayesian samplers	9
Population pharmacokinetics of belantamab mafodotin, a BCMA‐targeting agent in patients with relapsed/refractory multiple myeloma	9
Application of SHAP values for inferring the optimal functional form of covariates in pharmacokinetic modeling	9
Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol	9
Physiologically‐based pharmacokinetic modeling to predict CYP3A4‐mediated drug‐drug interactions of finerenone	9
SAMBA: A novel method for fast automatic model building in nonlinear mixed‐effects models	9
Population pharmacokinetic modeling and simulation to support qualification of pyridoxic acid as endogenous biomarker of OAT1/3 renal transporters	9
Examination of Physiologically‐Based Pharmacokinetic Models of Rosuvastatin	9
Conditional distribution modeling as an alternative method for covariates simulation: Comparison with joint multivariate normal and bootstrap techniques	8
Multi‐model averaging improves the performance of model‐guided infliximab dosing in patients with inflammatory bowel diseases	8
Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease	8
Easy and reliable maximum a posteriori Bayesian estimation of pharmacokinetic parameters with the open‐source R package mapbayr	8
Comparing the applications of machine learning, PBPK, and population pharmacokinetic models in pharmacokinetic drug–drug interaction prediction	8
Physiologically‐based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate	8
Population pharmacokinetic‐pharmacodynamic analyses of amyloid positron emission tomography and plasma biomarkers for lecanemab in subjects with early Alzheimer's disease	8
Estimating fetal exposure to the P‐gp substrates, corticosteroids, by PBPK modeling to inform prevention of neonatal respiratory distress syndrome	8
PK/PD modeling analysis for dosing regimen selection of isatuximab as single agent and in combination therapy in patients with multiple myeloma	8
Population pharmacokinetic and exposure–response analyses of intravenous and subcutaneous rituximab in patients with chronic lymphocytic leukemia	8
Pharmacokinetic Characterization to Enable Medicine Use in Pregnancy, the Potential Role of Physiologically‐Based Pharmacokinetic Modeling: A Regulatory Perspective	8
Development and application of a pediatric mechanistic kidney model	7
Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis	7
An introduction to the full random effects model	7
Pharmacokinetic‐pharmacodynamic modelling of the anti‐FcRn monoclonal antibody rozanolixizumab: Translation from preclinical stages to the clinic	7
Potential Issues With Virtual Populations When Applied to Nonlinear Quantitative Systems Pharmacology Models	7
Population pharmacokinetic analysis of dupilumab in adult and adolescent patients with asthma	7
The potential and pitfalls of artificial intelligence in clinical pharmacology	7
Development and Application of a Mechanistic Population Modeling Approach to Describe Abemaciclib Pharmacokinetics	7
Physiologically‐based pharmacokinetic modeling of oxcarbazepine and levetiracetam during adjunctive antiepileptic therapy in children and adolescents	7
Efficient and relevant stepwise covariate model building for pharmacometrics	7
A quantitative systems pharmacology approach to support mRNA vaccine development and optimization	7
Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y12 receptor between selatogrel and oral P2Y12 antagonists	7
Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin	7
Modeling restoration of gefitinib efficacy by co‐administration of MET inhibitors in an EGFR inhibitor‐resistant NSCLC xenograft model: A tumor‐in‐host DEB‐based approach	7
Optimized sampling to estimate vancomycin drug exposure: Comparison of pharmacometric and equation‐based approaches in a simulation‐estimation study	7
Population pharmacokinetic modeling of molibresib and its active metabolites in patients with solid tumors: A semimechanistic autoinduction model	7
Beyond the single average tumor: Understanding IO combinations using a clinical QSP model that incorporates heterogeneity in patient response	7
A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development	7
Application of a dual mechanistic approach to support bilastine dose selection for older adults	7
Tumor growth inhibition modeling of individual lesion dynamics and interorgan variability in HER2‐negative breast cancer patients treated with docetaxel	7
Detecting placebo and drug effects on Parkinson's disease symptoms by longitudinal item‐score models	7
Pretomanid dose selection for pulmonary tuberculosis: An application of multi‐objective optimization to dosage regimen design	7
Consistent methods for fat‐free mass, creatinine clearance, and glomerular filtration rate to describe renal function from neonates to adults	7
Development of physiologically‐based pharmacokinetic models for standard of care and newer tuberculosis drugs	7
Elevated acute phase proteins affect pharmacokinetics in COVID‐19 trials: Lessons from the CounterCOVID ‐ imatinib study	7
Pharm‐AutoML: An open‐source, end‐to‐end automated machine learning package for clinical outcome prediction	7
A continued learning approach for model‐informed precision dosing: Updating models in clinical practice	7
Delineating gene–environment effects using virtual twins of patients treated with clozapine	7
Clinical Trial Simulation To Optimize Trial Design for Fludarabine Dosing Strategies in Allogeneic Hematopoietic Cell Transplantation	6
Estimation of Equipotent Doses for Anti‐Inflammatory Effects of Prednisolone and AZD9567, an Oral Selective Nonsteroidal Glucocorticoid Receptor Modulator	6
Model‐informed target identification and validation through combining quantitative systems pharmacology with network‐based analysis	6
Mechanistic modeling of generic orally inhaled drug products: A workshop summary report	6
Use of physiologically‐based pharmacokinetic modeling to inform dosing of the opioid analgesics fentanyl and methadone in children with obesity	6
An introduction to causal inference for pharmacometricians	6
Erdafitinib’s effect on serum phosphate justifies its pharmacodynamically guided dosing in patients with cancer	6
CPT: Pharmacometrics & Systems Pharmacology – Inception, Maturation, and Future Vision	6
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations	6
Model‐based prediction of effective target exposure for MEN1611 in combination with trastuzumab in HER2‐positive advanced or metastatic breast cancer patients	6
Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework	6
Exposure–response analysis of efficacy and safety for pexidartinib in patients with tenosynovial giant cell tumor	6
Virtual clinical trial simulations for a novel KRASG12C inhibitor (ASP2453) in non‐small cell lung cancer	6
Pharmacometrics meets statistics—A synergy for modern drug development	6
Exposure‐Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis‐Associated Pain	6
Pharmacometric analyses of alectinib to facilitate approval of the optimal dose for the first‐line treatment of anaplastic lymphoma kinase–positive non‐small cell lung cancer	6

Estimands—What they are and why they are important for pharmacometricians	6
Variability in the Log Domain and Limitations to Its Approximation by the Normal Distribution	6
Virtual clinical trials: A tool for predicting patients who may benefit from treatment beyond progression with pembrolizumab in non‐small cell lung cancer	6
Prediction of cytochromes P450 3A and 2C19 modulation by both inflammation and drug interactions using physiologically based pharmacokinetics	6
Population pharmacokinetic analysis of rivaroxaban in children and comparison to prospective physiologically‐based pharmacokinetic predictions	6
Physiologically‐based pharmacokinetic modeling to predict drug interactions of lemborexant with CYP3A inhibitors	6
Semimechanistic Clearance Models of Oncology Biotherapeutics and Impact of Study Design: Cetuximab as a Case Study	6
Mechanistically modeling peripheral cytokine dynamics following bispecific dosing in solid tumors	6
Evaluation of drug–drug interaction potential for pemigatinib using physiologically based pharmacokinetic modeling	6
Model‐based meta‐analysis of changes in circulatory system physiology in patients with chronic heart failure	5
Salvaging CNS Clinical Trials Halted Due to COVID‐19	5
Growth‐rate model predicts in vivo tumor response from in vitro data	5
Development of and insights from systems pharmacology models of antibody‐drug conjugates	5
Predictions of Systemic, Intracellular, and Lung Concentrations of Azithromycin With Different Dosing Regimens Used in COVID‐19 Clinical Trials	5
A Physiologically‐Based Quantitative Systems Pharmacology Model of the Incretin Hormones GLP‐1 and GIP and the DPP4 Inhibitor Sitagliptin	5
Prediction of the drug–drug interaction potential of the α1‐acid glycoprotein bound, CYP3A4/CYP2C9 metabolized oncology drug, erdafitinib	5
Population pharmacokinetics of mobocertinib in healthy volunteers and patients with non–small cell lung cancer	5
Does the choice of applied physiologically‐based pharmacokinetics platform matter? A case study on simvastatin disposition and drug–drug interaction	5
Population pharmacokinetic model for once‐daily intravenous busulfan in pediatric subjects describing time‐associated clearance	5
An age‐dependent mathematical model of neurofilament trafficking in healthy conditions	5
Evaluation of covariate effects using forest plots and introduction to the coveffectsplot R package	5
Individualized Absorption Models in Population Pharmacokinetic Analyses	5
Physiologically based pharmacokinetic modeling of levetiracetam to predict the exposure in hepatic and renal impairment and elderly populations	5
Dose/exposure–response modeling in dose titration trials: Overcoming the titration paradox	5
End‐to‐end application of model‐informed drug development for ertugliflozin, a novel sodium‐glucose cotransporter 2 inhibitor	5
The use of extrapolation based on modeling and simulation to support high‐dose regimens of ceftaroline fosamil in pediatric patients with complicated skin and soft‐tissue infections	5
Model enhanced reinforcement learning to enable precision dosing: A theoretical case study with dosing of propofol	5
Population Pharmacokinetics and Exposure–Response of Luspatercept, an Erythroid Maturation Agent, in Anemic Patients With Myelodysplastic Syndromes	5
Cytochrome P450 2D6 genotype–phenotype characterization through population pharmacokinetic modeling of tedatioxetine	5
R and nlmixr as a gateway between statistics and pharmacometrics	5
Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop	5
Quantitative systems pharmacology model of the amyloid pathway in Alzheimer's disease: Insights into the therapeutic mechanisms of clinical candidates	5
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report	5
A combined physiologically‐based pharmacokinetic and quantitative systems pharmacology model for modeling amyloid aggregation in Alzheimer's disease	5
Verifying in vitro‐determined enzyme contributions to cannabidiol clearance for exposure predictions in human through physiologically‐based pharmacokinetic modeling	5
Performance of Cox proportional hazard models on recovering the ground truth of confounded exposure–response relationships for large‐molecule oncology drugs	5