CPT-Pharmacometrics & Systems Pharmacology

Article	Citations
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Development of a physiologically based pharmacokinetic model of fostemsavir and its pivotal application to support dosing in pregnancy	36
Association between SARS‐CoV‐2 viral kinetics and clinical score evolution in hospitalized patients	34
Evaluation of postprandial total triglycerides within the TIGG model for characterizing postprandial response of glucose, insulin, and GLP‐1	28
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Enhance Multistate Models With Clinically Meaningful Graphs	25
Correction to Network module‐based drug repositioning for pulmonary arterial hypertension	24
Quantitative Systems Pharmacology Model to Predict Target Occupancy by Bruton Tyrosine Kinase Inhibitors in Patients With B‐Cell Malignancies	24
A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II	24
Physiologically‐based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population	24
Clinical pharmacokinetics of leriglitazone and a translational approach using PBPK modeling to guide the selection of the starting dose in children	24
Prediction of a CLDN18.2 Targeted Antibody Drug Conjugate Pharmacokinetics in Cancer Patients Using PBPK Modeling and Simulation	22
Physiologically‐based pharmacokinetic model of sparsentan to evaluate drug–drug interaction potential	22
A Quantitative Systems Pharmacology (QSP) Model of Acute Hepatitis B Virus Infection: Mechanistic Insights and Foundations for Future Extensions	21
Exposure–response modeling for nausea incidence for cotadutide using a Markov modeling approach	21
Tutorial on Causal Mediation Analysis for Pharmacometricians	21
Mathematical model of the relationship between pH holding time and erosive esophagitis healing rates	21
Evaluation of covariate effects in item response theory models	21
Adaptive Dosing Trial Simulation Framework to Inform Dose Optimization: Case Study Using Longitudinal PKPD Models With PF	20
Pharmacokinetics of Intrapartum Benzylpenicillin: Insights Into Candidate Regimens to Prevent Early Onset Neonatal Group B Streptococcus Disease	19
Translational Physiologically Based Pharmacokinetic Modeling to Predict Human Pulmonary Kinetics After Lung Delivery	19
Designing phase I oncology dose escalation using dose–exposure–toxicity models as a complementary approach to model‐based dose–toxicity models	19

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report	19
Building Hybrid Pharmacometric‐Machine Learning Models in Oncology Drug Development: Current State and Recommendations	19
A systematic efficacy analysis of tuberculosis treatment with BPaL‐containing regimens using a multiscale modeling approach	19
Concentration‐QTc and cardiac safety analysis of single and multiple zavegepant nasal spray doses in healthy participants to support approval	19
Impact of Mechanistic Modeling and Simulation Methodologies on Product‐Specific Guidance Development for Non‐Orally Administered Drug Products	18
Pharmacometric and statistical considerations for dose optimization	18
Genotype, Ethnicity, and Drug–Drug Interaction Modeling as Means of Verifying Transporter Biomarker PBPK Model: The Coproporphyrin‐I Story	18
Characterization of mavacamten pharmacokinetics in patients with hypertrophic cardiomyopathy to inform dose titration	17
Predictive AI in Clinical Pharmacology: A Call to Action to Develop Robust Benchmarking Practices	17
Application of physiologically‐based pharmacokinetic model approach to predict pharmacokinetics and drug–drug interaction of rivaroxaban: A case study of rivaroxaban and carbamazepine	17
The Role of Estradiol in Oxidative Stress in Health and Cystathionine ß‐Synthase Deficiency: A Mechanistic Model	17
Using Virtual Patients to Evaluate Dosing Strategies for Bispecifics With a Bell‐Shaped Efficacy Curve	17
Talazoparib Formulation Bridging in Cancer Patients—Challenges and the Critical Role of Model‐Informed Drug Development in Approval Despite Failed Bioequivalence	17
Interspecies and in vitro‐in vivo scaling for quantitative modeling of whole‐body drug pharmacokinetics in patients: Application to the anticancer drug oxaliplatin	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
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Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women	17
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Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report	16
The population pharmacokinetics of dolutegravir co‐administered with rifampicin in Thai people living with HIV: Assessment of alternative dosing regimens	16
Retrieval Augmented Generation ( RAG ) for Evaluating Regulatory Compliance of Drug Information and Clinical Trial Protocols	16
Quantitative systems toxicology modeling in pharmaceutical research and development: An industry‐wide survey and selected case study examples	16
Shap‐Cov: An Explainable Machine Learning Based Workflow for Rapid Covariate Identification in Population Modeling	16
Tutorial on model selection and validation of model input into precision dosing software for model‐informed precision dosing	15
Mechanistic pharmacokinetic–pharmacodynamic modeling and simulations of naloxone auto‐injector 10 mg reversal of opioid‐induced respiratory depression	15
Development and Verification of a Physiologically Based Pharmacokinetic Model of Furmonertinib and Its Main Metabolite for Drug–Drug Interaction Predictions	15
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Physiologically‐based pharmacokinetic pharmacodynamic parent‐metabolite model of edoxaban to predict drug–drug‐disease interactions: M4 contribution	15
Population Pharmacokinetics and Transfer of Gabapentin When Used as a Pain Adjunct for Cesarean Deliveries	15
Pharmacokinetic/pharmacodynamic analysis of geographic atrophy lesion area in patients receiving pegcetacoplan treatment or sham	15
The interaction of core modules as a basis for elucidating network behavior determining Parkinson's disease pathogenesis	15
Precision Medicine in Oncology: Imatinib Dosing in the Obese Cancer Population Using Virtual Clinical Trials	15
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A mechanistic PK/PD model of AZD0171 (anti‐LIF) to support Phase II dose selection	14
Physiologically based mechanistic insight into differential risk of valproate hepatotoxicity between children and adults: A focus on ontogeny impact	14
Population pharmacokinetic and pharmacodynamic model of evogliptin: Severe uremia increases the bioavailability of evogliptin	14
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Variable or variate? A conundrum in pharmacometrics exposure–response models	14
Modeling of Disease Progression of Type 2 Diabetes Using Real‐World Data: Quantifying Competing Risks of Morbidity and Mortality	13
CYTOCON: The manually curated database of human in vivo cell and molecule concentrations	13
A physiologically‐based pharmacokinetic modeling approach for dosing amiodarone in children on ECMO	13
Tutorial for Modeling Delays in Biological Systems in the NONMEM Software	13
Population PK – PD Modeling of Danicopan Add‐On Therapy in Participants With Paroxysmal Nocturnal	13
SCOUT: An Exploratory Approach to Scouting Dose‐Relevant Covariates	13
Activity and perspective on quantitative modeling and simulation in Japan: Update from the Pharmaceuticals and Medical Devices Agency	13
Physiologically based pharmacokinetic modeling of drug–drug interactions between ritonavir‐boosted atazanavir and rifampicin in pregnancy	13
Multivariate modeling of magnetic resonance biomarkers and clinical outcome measures for Duchenne muscular dystrophy clinical trials	13
Midazolam Dosing During CRRT: A Combined Ex Vivo and Physiologically‐Based Pharmacokinetic Approach	13
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Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps	12

Population pharmacokinetic modeling of zavegepant, a calcitonin gene‐related peptide receptor antagonist, in healthy adults and patients with migraine	12
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Type 1 diabetes prevention clinical trial simulator: Case reports of model‐informed drug development tool	12
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Population PK modeling of certolizumab pegol in pregnant women with chronic inflammatory diseases	12
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	12
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Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview	12
Quantitative Systems Toxicology Modeling of Acetaminophen Pharmacokinetics and Hepatic Biomarkers After Overdoses of Extended‐Release and Immediate‐Release Formulations in Adults With Chronic Alcohol	12
Physiologically‐based pharmacokinetic modeling for investigating the effect of simeprevir on concomitant drugs and an endogenous biomarker of OATP1B	12
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Predicting Residual 21‐Hydroxylase Enzymatic Activity in Pediatric and Adult Congenital Adrenal Hyperplasia Patients: Towards Individualized Therapy	12
The influence of flip‐flop in population pharmacokinetic analyses	11
Model‐based meta‐analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus	11
Development of a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified‐Release Tablets	11
Mid‐dosing interval concentration is important for polymyxin B exposure and acute kidney injury in critically ill patients	11
A Pragmatic Approach to Handling Censored Data Below the Lower Limit of Quantification in Pharmacokinetic Modeling	11
Population pharmacokinetics modeling and exposure‐response analyses of cemiplimab in patients with recurrent or metastatic cervical cancer	11
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Evaluation of the Drug–Drug Interaction Potential of the GlyT1 Inhibitor Iclepertin (BI 425809): A Physiologically Based Pharmacokinetic (PBPK) Modeling Approach	11
Maximum likelihood estimation of renal transporter ontogeny profiles for pediatric PBPK modeling	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
Elucidating Contributions of Drug Transporters/Enzyme to Nonlinear Pharmacokinetics of Grazoprevir by PBPK Modeling With a Cluster Gauss–Newton Method	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
Low‐dimensional neural ordinary differential equations accounting for inter‐individual variability implemented in Monolix and NONMEM	11
Population pharmacokinetics of intraperitoneal irinotecan and SN‐38 in patients with peritoneal metastases from colorectal origin	10
Population Pharmacokinetic and Exposure‐Response Analyses of Ibrutinib Combined With Bendamustine and Rituximab in Patients With Mantle Cell Lymphoma	10
Quantitative systems pharmacology model of the amyloid pathway in Alzheimer's disease: Insights into the therapeutic mechanisms of clinical candidates	10
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Impact of Event‐Related Treatment Modifications in Exposure‐Response Analyses of Repeated Time‐to‐Event Data	10
Quantitative systems pharmacology in the age of artificial intelligence	10
Semi‐Mechanistic Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Dupilumab on Pre‐Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	10
An Interactive Pharmacokinetic‐Pharmacodynamic Framework to Evaluate Bedaquiline Dose Modifications in Adults With Tuberculosis	10
DDIapp —A Web‐Based Application for Static Drug–Drug Interaction Assessment	10
Population pharmacokinetic modeling of oral brepocitinib in healthy volunteers and patients with immuno‐inflammatory diseases	10
A literature review of drug transport mechanisms during lactation	10
Open Systems Pharmacology Community Conference ( OSP ‐ CC ) Proceedings 2025	10
Moving From Point‐Based Analysis to Systems‐Based Modeling: Knowledge Integration to Address Antimicrobial Resistance	10
PBPK modeling: What is the role of CYP3A4 expression in the gastrointestinal tract to accurately predict first‐pass metabolism?	10
Semimechanistic modeling of copeptin and aldosterone kinetics and dynamics in response to rehydration treatment for diabetic ketoacidosis in children	10
Elucidating nonlinear pharmacokinetics of telmisartan: Integration of target‐mediated drug disposition and OATP1B3‐mediated hepatic uptake in a physiologically based model	10
Post‐Marketing Requirements for Anticancer Drugs Approved in Japan, 2001–2024: A Cross‐Sectional Analysis	10
Continuous‐Time Markov Population PK/PD Modeling of Longitudinal EASI Categorical Score in Atopic Dermatitis Treated With Rocatinlimab, an Anti‐OX40 Monoclonal Antibody	10
Toward improved predictions of pharmacokinetics of transported drugs in hepatic impairment: Insights from the extended clearance model	10
Causal Directed Acyclic Graphs to Mitigate Confounding Bias in Exposure‐Response Analyses	10
Item performance of the scale for the assessment and rating of ataxia in rare and ultra‐rare genetic ataxias	10
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State‐of‐the‐Art on Model‐Informed Drug Development Approaches for Pediatric Rare Diseases	9
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Predicting the correct dose in children: Role of computational Pediatric Physiological‐based pharmacokinetics modeling tools	9
Mechanistic modeling projections of antibody persistence after homologous booster regimens of COVID‐19 vaccine Ad26.COV2.S in humans	9
Development of a cystic fibrosis population model for physiologically based pharmacokinetic models: Is it worth it?	9
Population pharmacokinetics of amodiaquine and piperaquine in African pregnant women with uncomplicated Plasmodium falciparum infections	9
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Machine Learning‐Based Model Selection and Averaging Outperform Single‐Model Approaches for a Priori Vancomycin Precision Dosing	9
Supplementing clinical lactation studies with PBPK modeling to inform drug therapy in lactating mothers: Prediction of primaquine exposure as a case example	9
A Pharmacometric Workflow for Resolving Model Instability in Model Use‐Reuse Settings	9
Population pharmacokinetic analysis for tisotumab vedotin in patients with locally advanced and/or metastatic solid tumors	9
PMX ‐ CovEval : A Framework Including a Simulated Pharmacokinetic Database for Covariate Model Building Methods Benchm	9
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Evaluation of the drug–drug interaction potential of brigatinib using a physiologically‐based pharmacokinetic modeling approach	9
Anti‐ PD ‐(L)1 Antibodies: Insights From QSP ‐Based Meta‐Analysis	9
Assessment and Benchmarking of Model Informed Approaches in Drug Development for Hemoglobinopathies: A Review of Scientific Advices From January 2000 to December 2024	9
Population pharmacokinetics and exposure–clinical outcome relationship of remdesivir major metabolite GS‐441524 in patients with moderate and severe COVID‐19	9
Population pharmacokinetic analyses for belzutifan to inform dosing considerations and labeling	9
Development and comparison of model‐integrated evidence approaches for bioequivalence studies with pharmacokinetic end points	9
Applying interpretable machine learning workflow to evaluate exposure–response relationships for large‐molecule oncology drugs	8
Population pharmacokinetics and exposure–response analyses of polatuzumab vedotin in patients with previously untreated DLBCL from the POLARIX study	8
QPRapp: A Web‐Based Platform for PK/PD Simulations and Early Feasibility Analysis	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
Physiologically based pharmacokinetic modeling for development and applications of a virtual celiac disease population using felodipine as a model drug	8
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective	8
Model‐Based Meta‐Analysis of the Relationship Between Pioglitazone and Histological Outcomes in Metabolic Dysfunction‐Associated Steatohepatitis Patients	8
Exposure‐Efficacy Meta‐Model of Nintedanib in Adult Patients With Chronic Fibrosing Interstitial Lung Diseases	8
Disease–Drug–Drug Interaction of Imatinib in COVID‐19 ARDS: A Pooled Population Pharmacokinetic Analysis	8
Response to “Enhance Multistate Models With Clinically Meaningful Graphs”	8
Albumin Levels Are Predictive of Cachexia‐Induced Time‐Dependent Clearance of Therapeutic Antibodies: A Physiologically Based Pharmacokinetic Model of Durvalumab	8
Population model‐based analysis of the memory B‐cell response following belimumab therapy in the treatment of systemic lupus erythematosus	8

Application of Physiologically‐Based Pharmacokinetic Modeling to Support Drug Labeling: Prediction of CYP3A4 ‐Mediated Pirtobrutinib‐Drug Interaction	8
Isavuconazole and Calcium Channel Blocker for Invasive Fungal Disease Accompanied With Hypertension: Evidence From the FAERS and PBPK/PD Model	8
Tackling High Dimensionality in QSP : Guiding Model Order Reduction With Index Analysis	8
Analyzing Pharmacodynamic Count Data That Rapidly Decrease to Zero	8
Postmarketing Assessment of Antibody–Drug Conjugates: Proof‐of‐Concept Using Model‐Based Meta‐Analysis and a Clinical Utility Index Approach	8
Within‐chain parallelization—Giving Stan Jet Fuel for population modeling in pharmacometrics	8
A Population Pharmacokinetic Model to Inform Extension of the Eteplirsen Dosing Regimen Across the Broad DMD Population	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
Impact of Obesity and MASH on Zonal Hepatocellular Statin Exposure: Pharmacodynamic Insights From a Permeability‐Limited Multicompartment Liver Model	7
Synthetic Model Combination: A new machine‐learning method for pharmacometric model ensembling	7
Delineating gene–environment effects using virtual twins of patients treated with clozapine	7
Population Pharmacokinetic Analysis of Datopotamab Deruxtecan (Dato‐ DXd ), a TROP2 ‐Directed Anti	7
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Development of a PBPK model to quantitatively understand absorption and disposition mechanism and support future clinical trials for PB‐201	7
Quantitative systems pharmacology model of α‐synuclein pathology in Parkinson's disease‐like mouse for investigation of passive immunotherapy mechanisms	7
Combining Aggregate Data and Individual Patient Data in Model‐Based Meta‐Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients	7
Development of a Joint Tumor Size–Overall Survival Modeling and Simulation Framework Supporting Oncology Development Decision‐Making	7
Mechanistic modeling of drug products applied to the skin: A workshop summary report	7
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Corrigendum to: 2022 WCoP Abstracts	7
Accelerating Subcutaneous Drug Development: A Mechanistic Absorption Model for the Open Systems Pharmacology Framework	7
Population Pharmacokinetic Model of Pegbing in Healthy Subjects and Chronic Hepatitis B Patients	7
The Regularized Horseshoe for Covariate Selection Improves Convenience and Predictive Performance in Population PK / PD	7
Pharmacokinetic Model‐Informed Precision Dosing of Natalizumab in Multiple Sclerosis	7
Stochastic Gates for Covariate Selection in Population Pharmacokinetics Modeling	7
A multi‐model approach to predict efficacious clinical dose for an anti‐TGF‐β antibody (GC2008) in the treatment of osteogenesis imperfecta	7
Population Pharmacokinetics and Exposure‐Response of Subcutaneous Atezolizumab in Patients With Non‐Small Cell Lung Cancer	7
Population Pharmacokinetics and Exposure‐Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1	7
Item Response Modeling and Artificial Neural Network for Differentiation of Parkinson's Patients and Subjects Without Evidence of Dopaminergic Deficit	7
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Optimizing the design of a pharmacokinetic trial to evaluate the dosing scheme of a novel tuberculosis drug in children living with or without HIV	7
Integrating MBMA and QSP to Identify Key Covariates and Predict Treatment Outcomes in Relapsed/Ref	7
Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report	7
Deep‐NCA: A deep learning methodology for performing noncompartmental analysis of pharmacokinetic data	7
Navigating the landscape of parameter identifiability methods: A workflow recommendation for model development	7
Using PBPK to Simulate Target Biopredictive Dissolution Profiles for Long‐Acting Injectables ‐ Where to Begin With Critical Bioavailability Attribute	7
A fully automatic tool for development of population pharmacokinetic models	7
Population Physiologically‐Based Pharmacokinetic Modeling to Determine Ontogeny: A Quantitative Clinical Pharmacology Example in Pediatric Rare Disease	7
In memoriam Lambertus (“Bert”) A. Peletier 29 March 1937–16 December 2023: Furthering quantitative pharmacology through applied mathematics	6
From In Vitro Efficacy to Long‐Term HbA1c Response for GLP‐1R/GlucagonR Agonism Using the 4GI‐HbA1c Systems Model	6
Quantitative Systems Pharmacology Modeling Amid the Rise of Agentic AI	6
Physiologically‐based pharmacokinetic modeling of immunoglobulin and antibody coadministration in patients with primary human immunodeficiency	6
Virtual Clinical Trial Reveals Significant Clinical Potential of Targeting Tumor‐Associated Macrophages and Microglia to Treat Glioblastoma	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
Population pharmacokinetic analysis of sparsentan in healthy volunteers and patients with focal segmental glomerulosclerosis	6
Hepatic OATP1B zonal distribution: Implications for rifampicin‐mediated drug–drug interactions explored within a PBPK framework	6
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Evaluation of the PK / PD Changes on MASLD ‐Rel	6
Skipping a pillar does not make for strong foundations: Pharmacokinetic‐pharmacodynamic reasoning behind the shape of dose–response relationships in oncology	6
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Current State‐of‐the‐Art and Future Advancements of Model‐Based Meta‐Analysis	6
Pharmacokinetics, Pharmacodynamics, Efficacy and Drug Resistance Selection of Injectable Long‐Acting Lenacapavir Pre‐Exposure Prophylaxis ( PrEP ) Ag	6
Unraveling the Link Between Azathioprine and Acute Pancreatitis: Integrating Network Toxicology, Machine Learning, and Mendelian Randomization	6
Application of longitudinal item response theory models to modeling Parkinson’s disease progression	6
Development and application of a PBPK modeling strategy to support antimalarial drug development	6
Informing pregnancy dose via target‐mediated drug disposition modeling and simulations for a recombinant human monoclonal antibody	6
Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB‐02) in Patients With Advanced Solid Tumors	6
Computational design of clinical trials using a combination of simulation and the genetic algorithm	6
Developmental pharmacokinetics of indomethacin in preterm neonates: Severely decreased drug clearance in the first week of life	6
Mixed‐effects models and the drug titration paradox	6
A Model‐Based Meta‐Analysis of Pembrolizumab Effects on Patient‐Reported Quality of Life: Advancing Patient‐Centered Oncology Drug Development	6
Multistate modeling for survival analysis in critically ill patients treated with meropenem	6
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PBPK Modeling to Predict Clinical Drug–Drug Interaction and Impact of Hepatic Impairment for an ADC With the Payload Auristatin F‐Hydroxypropylamide	6
Development of the Weight‐Tiered Q3W Regimen of Amivantamab in Combination With Carboplatin‐Pemetrexed in EGFR	6
Preclinical side effect prediction through pathway engineering of protein interaction network models	6
Model‐based prediction of progression‐free survival for combination therapies in oncology	6
Model‐Informed Dosing Regimen of Sugemalimab for European Patients With Non‐Small Cell Lung Cancer: Bridging From Asian Clinical Data	6