CPT-Pharmacometrics & Systems Pharmacology

Article	Citations
Issue Information	46
Issue Information	44
Evaluation of covariate effects in item response theory models	38
Issue Information	33
Correction to Network module‐based drug repositioning for pulmonary arterial hypertension	32
Issue Information	32
Concentration‐QTc and cardiac safety analysis of single and multiple zavegepant nasal spray doses in healthy participants to support approval	32
Association between SARS‐CoV‐2 viral kinetics and clinical score evolution in hospitalized patients	30
A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II	30
Evaluation of postprandial total triglycerides within the TIGG model for characterizing postprandial response of glucose, insulin, and GLP‐1	28
A systematic efficacy analysis of tuberculosis treatment with BPaL‐containing regimens using a multiscale modeling approach	27
Building Hybrid Pharmacometric‐Machine Learning Models in Oncology Drug Development: Current State and Recommendations	27
Physiologically‐based pharmacokinetic model of sparsentan to evaluate drug–drug interaction potential	27
Prediction of a CLDN18.2 Targeted Antibody Drug Conjugate Pharmacokinetics in Cancer Patients Using PBPK Modeling and Simulation	26
Pharmacokinetics of Intrapartum Benzylpenicillin: Insights Into Candidate Regimens to Prevent Early Onset Neonatal Group B Streptococcus Disease	26
Pharmacometric and statistical considerations for dose optimization	25
Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations	24
Exposure–response modeling for nausea incidence for cotadutide using a Markov modeling approach	24
Designing phase I oncology dose escalation using dose–exposure–toxicity models as a complementary approach to model‐based dose–toxicity models	24
Clinical pharmacokinetics of leriglitazone and a translational approach using PBPK modeling to guide the selection of the starting dose in children	24
Issue Information	23
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report	23
Translational Physiologically Based Pharmacokinetic Modeling to Predict Human Pulmonary Kinetics After Lung Delivery	23
A Quantitative Systems Pharmacology (QSP) Model of Acute Hepatitis B Virus Infection: Mechanistic Insights and Foundations for Future Extensions	23
Enhance Multistate Models With Clinically Meaningful Graphs	22

Quantitative Systems Pharmacology Model to Predict Target Occupancy by Bruton Tyrosine Kinase Inhibitors in Patients With B‐Cell Malignancies	22
Step‐by‐step comparison of ordinary differential equation and agent‐based approaches to pharmacokinetic‐pharmacodynamic models	21
Development of a physiologically based pharmacokinetic model of fostemsavir and its pivotal application to support dosing in pregnancy	20
Physiologically‐based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population	20
Update to improve reproducibility and interpretability: A response to “Machine Learning for Tumor Growth Inhibition”	18
Physiologically‐based pharmacokinetic pharmacodynamic parent‐metabolite model of edoxaban to predict drug–drug‐disease interactions: M4 contribution	18
Genotype, Ethnicity, and Drug–Drug Interaction Modeling as Means of Verifying Transporter Biomarker PBPK Model: The Coproporphyrin‐I Story	18
Impact of Mechanistic Modeling and Simulation Methodologies on Product‐Specific Guidance Development for Non‐Orally Administered Drug Products	18
Mathematical model of the relationship between pH holding time and erosive esophagitis healing rates	18
Quantitative systems toxicology modeling in pharmaceutical research and development: An industry‐wide survey and selected case study examples	17
Shap‐Cov: An Explainable Machine Learning Based Workflow for Rapid Covariate Identification in Population Modeling	17
Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women	17
The population pharmacokinetics of dolutegravir co‐administered with rifampicin in Thai people living with HIV: Assessment of alternative dosing regimens	17
Model‐based simulation to support the approval of isatuximab alone or with dexamethasone for the treatment of relapsed/refractory multiple myeloma in Japanese patients	17
Interspecies and in vitro‐in vivo scaling for quantitative modeling of whole‐body drug pharmacokinetics in patients: Application to the anticancer drug oxaliplatin	16
Pharmacokinetic/pharmacodynamic analysis of geographic atrophy lesion area in patients receiving pegcetacoplan treatment or sham	16
Predictive AI in Clinical Pharmacology: A Call to Action to Develop Robust Benchmarking Practices	16
Application of physiologically‐based pharmacokinetic model approach to predict pharmacokinetics and drug–drug interaction of rivaroxaban: A case study of rivaroxaban and carbamazepine	15
Talazoparib Formulation Bridging in Cancer Patients—Challenges and the Critical Role of Model‐Informed Drug Development in Approval Despite Failed Bioequivalence	15
Characterization of mavacamten pharmacokinetics in patients with hypertrophic cardiomyopathy to inform dose titration	15
Using Virtual Patients to Evaluate Dosing Strategies for Bispecifics With a Bell‐Shaped Efficacy Curve	15
Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report	15
The interaction of core modules as a basis for elucidating network behavior determining Parkinson's disease pathogenesis	14
Issue Information	14
Tutorial on model selection and validation of model input into precision dosing software for model‐informed precision dosing	14
Development and Verification of a Physiologically Based Pharmacokinetic Model of Furmonertinib and Its Main Metabolite for Drug–Drug Interaction Predictions	14
Mechanistic pharmacokinetic–pharmacodynamic modeling and simulations of naloxone auto‐injector 10 mg reversal of opioid‐induced respiratory depression	14
Tutorial for Modeling Delays in Biological Systems in the NONMEM Software	14
	13
A mechanistic PK/PD model of AZD0171 (anti‐LIF) to support Phase II dose selection	13
	13
Flexible and efficient Bayesian pharmacometrics modeling using Stan and Torsten, Part I	13
Modeling of Disease Progression of Type 2 Diabetes Using Real‐World Data: Quantifying Competing Risks of Morbidity and Mortality	13
Variable or variate? A conundrum in pharmacometrics exposure–response models	13
Precision Medicine in Oncology: Imatinib Dosing in the Obese Cancer Population Using Virtual Clinical Trials	13
Physiologically based pharmacokinetic modeling of drug–drug interactions between ritonavir‐boosted atazanavir and rifampicin in pregnancy	13
	13
Population Pharmacokinetics and Transfer of Gabapentin When Used as a Pain Adjunct for Cesarean Deliveries	13
Population pharmacokinetic and pharmacodynamic model of evogliptin: Severe uremia increases the bioavailability of evogliptin	13
CYTOCON: The manually curated database of human in vivo cell and molecule concentrations	13
Longitudinal and time‐to‐event modeling for prognostic implications of radical surgery in retroperitoneal sarcoma	12
Issue Information	12
	12
Physiologically based mechanistic insight into differential risk of valproate hepatotoxicity between children and adults: A focus on ontogeny impact	12
	12
Machine learning algorithms to estimate everolimus exposure trained on simulated and patient pharmacokinetic profiles	12
Activity and perspective on quantitative modeling and simulation in Japan: Update from the Pharmaceuticals and Medical Devices Agency	12
A physiologically‐based pharmacokinetic modeling approach for dosing amiodarone in children on ECMO	12
Multivariate modeling of magnetic resonance biomarkers and clinical outcome measures for Duchenne muscular dystrophy clinical trials	12
	12

	11
A Model‐Based Approach to Evaluate Anti‐Drug Antibody Impact on Drug Exposure With Biologics: A Case Example With the CD3 T‐Cell Bispecific Cibisatamab	11
Model‐based meta‐analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus	11
Elucidating Contributions of Drug Transporters/Enzyme to Nonlinear Pharmacokinetics of Grazoprevir by PBPK Modeling With a Cluster Gauss–Newton Method	11
Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps	11
Issue Information	11
Quantitative Systems Toxicology Modeling of Acetaminophen Pharmacokinetics and Hepatic Biomarkers After Overdoses of Extended‐Release and Immediate‐Release Formulations in Adults With Chronic Alcohol	11
Evaluation of the potential impact on pharmacokinetics of various cytochrome P450 substrates of increasing IL‐6 levels following administration of the T‐cell bispecific engager g	11
Issue Information	11
Quantitative system pharmacology as a legitimate approach to examine extrapolation strategies used to support pediatric drug development	11
Multi‐model averaging improves the performance of model‐guided infliximab dosing in patients with inflammatory bowel diseases	10
Maximum likelihood estimation of renal transporter ontogeny profiles for pediatric PBPK modeling	10
Development of and insights from systems pharmacology models of antibody‐drug conjugates	10
Mid‐dosing interval concentration is important for polymyxin B exposure and acute kidney injury in critically ill patients	10
Population Pharmacokinetic and Exposure‐Response Analyses of Ibrutinib Combined With Bendamustine and Rituximab in Patients With Mantle Cell Lymphoma	10
Type 1 diabetes prevention clinical trial simulator: Case reports of model‐informed drug development tool	10
A Pragmatic Approach to Handling Censored Data Below the Lower Limit of Quantification in Pharmacokinetic Modeling	10
Semimechanistic modeling of copeptin and aldosterone kinetics and dynamics in response to rehydration treatment for diabetic ketoacidosis in children	10
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview	10
Population PK modeling of certolizumab pegol in pregnant women with chronic inflammatory diseases	10
Quantitative systems pharmacology model of the amyloid pathway in Alzheimer's disease: Insights into the therapeutic mechanisms of clinical candidates	10
Issue Information	10
Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non‐small cell lung cancer based on bintrafusp alfa trials	10
Predicting Residual 21‐Hydroxylase Enzymatic Activity in Pediatric and Adult Congenital Adrenal Hyperplasia Patients: Towards Individualized Therapy	10
The influence of flip‐flop in population pharmacokinetic analyses	10
Population pharmacokinetic modeling of oral brepocitinib in healthy volunteers and patients with immuno‐inflammatory diseases	10
Population pharmacokinetics modeling and exposure‐response analyses of cemiplimab in patients with recurrent or metastatic cervical cancer	10
Evaluation of the Drug–Drug Interaction Potential of the GlyT1 Inhibitor Iclepertin (BI 425809): A Physiologically Based Pharmacokinetic (PBPK) Modeling Approach	10
Physiologically‐based pharmacokinetic modeling for investigating the effect of simeprevir on concomitant drugs and an endogenous biomarker of OATP1B	10
Machine Learning‐Based Model Selection and Averaging Outperform Single‐Model Approaches for a Priori Vancomycin Precision Dosing	10
Low‐dimensional neural ordinary differential equations accounting for inter‐individual variability implemented in Monolix and NONMEM	10
Population pharmacokinetic modeling of zavegepant, a calcitonin gene‐related peptide receptor antagonist, in healthy adults and patients with migraine	10
Item performance of the scale for the assessment and rating of ataxia in rare and ultra‐rare genetic ataxias	10
PBPK modeling: What is the role of CYP3A4 expression in the gastrointestinal tract to accurately predict first‐pass metabolism?	9
State‐of‐the‐Art on Model‐Informed Drug Development Approaches for Pediatric Rare Diseases	9
Continuous‐Time Markov Population PK/PD Modeling of Longitudinal EASI Categorical Score in Atopic Dermatitis Treated With Rocatinlimab, an Anti‐OX40 Monoclonal Antibody	9
Population pharmacokinetics of intraperitoneal irinotecan and SN‐38 in patients with peritoneal metastases from colorectal origin	9
Issue Information	9
Development of a cystic fibrosis population model for physiologically based pharmacokinetic models: Is it worth it?	9
	9
	9
Elucidating nonlinear pharmacokinetics of telmisartan: Integration of target‐mediated drug disposition and OATP1B3‐mediated hepatic uptake in a physiologically based model	9
Moving From Point‐Based Analysis to Systems‐Based Modeling: Knowledge Integration to Address Antimicrobial Resistance	9
Semi‐Mechanistic Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Dupilumab on Pre‐Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	9
Quantitative approaches to drug safety: The 2022 PSP special issue	9
Issue Information	9
Population pharmacokinetics and exposure–clinical outcome relationship of remdesivir major metabolite GS‐441524 in patients with moderate and severe COVID‐19	9
Population pharmacokinetics of amodiaquine and piperaquine in African pregnant women with uncomplicated Plasmodium falciparum infections	9
Quantitative systems pharmacology in the age of artificial intelligence	9
Evaluation of the drug–drug interaction potential of brigatinib using a physiologically‐based pharmacokinetic modeling approach	9
Toward improved predictions of pharmacokinetics of transported drugs in hepatic impairment: Insights from the extended clearance model	9
A literature review of drug transport mechanisms during lactation	9
Model‐Based Meta‐Analysis of the Relationship Between Pioglitazone and Histological Outcomes in Metabolic Dysfunction‐Associated Steatohepatitis Patients	9
Within‐chain parallelization—Giving Stan Jet Fuel for population modeling in pharmacometrics	9
Population pharmacokinetics of mobocertinib in healthy volunteers and patients with non–small cell lung cancer	9
Deep‐NCA: A deep learning methodology for performing noncompartmental analysis of pharmacokinetic data	8
Postmarketing Assessment of Antibody–Drug Conjugates: Proof‐of‐Concept Using Model‐Based Meta‐Analysis and a Clinical Utility Index Approach	8
A Pharmacometric Workflow for Resolving Model Instability in Model Use‐Reuse Settings	8
Finding the right hazard function for time‐to‐event modeling: A tutorial and Shiny application	8
Population pharmacokinetic analyses for belzutifan to inform dosing considerations and labeling	8
Isavuconazole and Calcium Channel Blocker for Invasive Fungal Disease Accompanied With Hypertension: Evidence From the FAERS and PBPK/PD Model	8
Physiologically based pharmacokinetic modeling for development and applications of a virtual celiac disease population using felodipine as a model drug	8
Applying interpretable machine learning workflow to evaluate exposure–response relationships for large‐molecule oncology drugs	8
Disease–Drug–Drug Interaction of Imatinib in COVID‐19 ARDS: A Pooled Population Pharmacokinetic Analysis	8
Supplementing clinical lactation studies with PBPK modeling to inform drug therapy in lactating mothers: Prediction of primaquine exposure as a case example	8
Predicting the correct dose in children: Role of computational Pediatric Physiological‐based pharmacokinetics modeling tools	8
Population model‐based analysis of the memory B‐cell response following belimumab therapy in the treatment of systemic lupus erythematosus	8
Mechanistic modeling projections of antibody persistence after homologous booster regimens of COVID‐19 vaccine Ad26.COV2.S in humans	8
Issue Information	8
Integrating MBMA and QSP to Identify Key Covariates and Predict Treatment Outcomes in Relapsed/Ref	8
Synthetic Model Combination: A new machine‐learning method for pharmacometric model ensembling	8
Population pharmacokinetic analysis for tisotumab vedotin in patients with locally advanced and/or metastatic solid tumors	8
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective	8
The area under the effect curve as an efficacy determinant for anti‐infectives	8
Application of Physiologically‐Based Pharmacokinetic Modeling to Support Drug Labeling: Prediction of CYP3A4 ‐Mediated Pirtobrutinib‐Drug Interaction	8
Development and comparison of model‐integrated evidence approaches for bioequivalence studies with pharmacokinetic end points	8
Physiologically‐based pharmacokinetic modeling for primary metabolites of CYP3A and P‐glycoprotein inhibitors in drug–drug interactions: Should we assume the free drug hypothesis?	8
Analyzing Pharmacodynamic Count Data That Rapidly Decrease to Zero	8
Quantitative methods and modeling to assess COVID‐19‐interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches	7
Population pharmacokinetics and exposure–response analyses of polatuzumab vedotin in patients with previously untreated DLBCL from the POLARIX study	7

Population Pharmacokinetics and Exposure‐Response of Subcutaneous Atezolizumab in Patients With Non‐Small Cell Lung Cancer	7
	7
Mechanistic modeling of drug products applied to the skin: A workshop summary report	7
Response to “Enhance Multistate Models With Clinically Meaningful Graphs”	7
Delineating gene–environment effects using virtual twins of patients treated with clozapine	7
Exposure‐Efficacy Meta‐Model of Nintedanib in Adult Patients With Chronic Fibrosing Interstitial Lung Diseases	7
Population PBPK modeling using parametric and nonparametric methods of the Simcyp Simulator, and Bayesian samplers	7
QPRapp: A Web‐Based Platform for PK/PD Simulations and Early Feasibility Analysis	7
Development of a Joint Tumor Size–Overall Survival Modeling and Simulation Framework Supporting Oncology Development Decision‐Making	7
	7
A multi‐model approach to predict efficacious clinical dose for an anti‐TGF‐β antibody (GC2008) in the treatment of osteogenesis imperfecta	7
A fully automatic tool for development of population pharmacokinetic models	7
Issue Information	7
A Population Pharmacokinetic Model to Inform Extension of the Eteplirsen Dosing Regimen Across the Broad DMD Population	7
Pharmacokinetic Model‐Informed Precision Dosing of Natalizumab in Multiple Sclerosis	7
Predicting disease activity in patients with multiple sclerosis: An explainable machine‐learning approach in the Mavenclad trials	7
Deep compartment models: A deep learning approach for the reliable prediction of time‐series data in pharmacokinetic modeling	7
Development of a PBPK model to quantitatively understand absorption and disposition mechanism and support future clinical trials for PB‐201	7
Issue Information	7
Model‐informed drug development of voxelotor in sickle cell disease: Population pharmacokinetics in whole blood and plasma	7
Abstracts	7
Corrigendum to: 2022 WCoP Abstracts	7
	7
A dynamic model of the intestinal epithelium integrates multiple sources of preclinical data and enables clinical translation of drug‐induced toxicity	7
Evaluation and Mitigation of Time‐Dependent Confounding Effects in Conventional Exposure‐Response Analyses for Oncology Drugs	7
Population Pharmacokinetic Analysis of Datopotamab Deruxtecan (Dato‐ DXd ), a TROP2 ‐Directed Anti	7
Item Response Modeling and Artificial Neural Network for Differentiation of Parkinson's Patients and Subjects Without Evidence of Dopaminergic Deficit	7
Quantitative systems pharmacology model of α‐synuclein pathology in Parkinson's disease‐like mouse for investigation of passive immunotherapy mechanisms	7
Multistate modeling for survival analysis in critically ill patients treated with meropenem	6
Developmental pharmacokinetics of indomethacin in preterm neonates: Severely decreased drug clearance in the first week of life	6
Navigating the landscape of parameter identifiability methods: A workflow recommendation for model development	6
A Model‐Based Meta‐Analysis of Pembrolizumab Effects on Patient‐Reported Quality of Life: Advancing Patient‐Centered Oncology Drug Development	6
Population pharmacokinetic analysis of sparsentan in healthy volunteers and patients with focal segmental glomerulosclerosis	6
Skipping a pillar does not make for strong foundations: Pharmacokinetic‐pharmacodynamic reasoning behind the shape of dose–response relationships in oncology	6
Hepatic OATP1B zonal distribution: Implications for rifampicin‐mediated drug–drug interactions explored within a PBPK framework	6
Population pharmacokinetic analysis of etrolizumab in patients with moderately‐to‐severely active ulcerative colitis	6
Application of longitudinal item response theory models to modeling Parkinson’s disease progression	6
Issue Information	6
Issue Information	6
Virtual Clinical Trial Reveals Significant Clinical Potential of Targeting Tumor‐Associated Macrophages and Microglia to Treat Glioblastoma	6
Impact of Obesity and MASH on Zonal Hepatocellular Statin Exposure: Pharmacodynamic Insights From a Permeability‐Limited Multicompartment Liver Model	6
Population Pharmacokinetic Model of Pegbing in Healthy Subjects and Chronic Hepatitis B Patients	6
Optimizing the design of a pharmacokinetic trial to evaluate the dosing scheme of a novel tuberculosis drug in children living with or without HIV	6
In memoriam Lambertus (“Bert”) A. Peletier 29 March 1937–16 December 2023: Furthering quantitative pharmacology through applied mathematics	6
Evaluation of the PK / PD Changes on MASLD ‐Rel	6
Effect of Cumulative Exposure on the Efficacy of Paroxetine: A Population Pharmacokinetic‐Pharmacodynamic and Machine Learning Analyses	6
PBPK perspective on alternative CYP3A4 inducers for rifampin	6
PBPK Modeling to Predict Clinical Drug–Drug Interaction and Impact of Hepatic Impairment for an ADC With the Payload Auristatin F‐Hydroxypropylamide	6
Physiologically‐based pharmacokinetic modeling of immunoglobulin and antibody coadministration in patients with primary human immunodeficiency	6
Growth‐rate model predicts in vivo tumor response from in vitro data	6
Mixed‐effects models and the drug titration paradox	6
Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report	6
From In Vitro Efficacy to Long‐Term HbA1c Response for GLP‐1R/GlucagonR Agonism Using the 4GI‐HbA1c Systems Model	6
Biased computation of probability of target attainment for antimicrobial drugs	6
Model‐based prediction of progression‐free survival for combination therapies in oncology	6
Population Pharmacokinetic Modeling and Pediatric Exposure of Dexamethasone Sodium Phosphate Encapsulated in Erythrocytes (eDSP) Administered Monthly for Treatment of Neurological Symptoms of Patients	6
Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB‐02) in Patients With Advanced Solid Tumors	6