OOIR: Observatory of International Research

Papers

(The TQCC of CPT-Pharmacometrics & Systems Pharmacology is 6. 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 2020-11-01 to 2024-11-01.)

Article	Citations
Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility	59
Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%	42
An artificial neural network−pharmacokinetic model and its interpretation using Shapley additive explanations	40
PK/PD modeling of FXI antisense oligonucleotides to bridge the dose‐FXI activity relation from healthy volunteers to end‐stage renal disease patients	30
A novel method based on unbiased correlations tests for covariate selection in nonlinear mixed effects models: The COSSAC approach	30
Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations	30
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration	30
Prediction of drug concentrations in milk during breastfeeding, integrating predictive algorithms within a physiologically‐based pharmacokinetic model	29
Approaches to handling missing or “problematic” pharmacology data: Pharmacokinetics	27
Quantitative prediction of breast cancer resistant protein mediated drug‐drug interactions using physiologically‐based pharmacokinetic modeling	27
A hybrid machine learning/pharmacokinetic approach outperforms maximum a posteriori Bayesian estimation by selectively flattening model priors	25
Guide to development of compound files for PBPK modeling in the Simcyp population‐based simulator	25
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	24
Opportunities and challenges for applying model‐informed drug development approaches to gene therapies	23
Reinforcement learning and Bayesian data assimilation for model‐informed precision dosing in oncology	23
Perspective on model‐informed drug development	22
A mechanism‐based pharmacokinetic model of remdesivir leveraging interspecies scaling to simulate COVID‐19 treatment in humans	22
Translational pharmacokinetic‐pharmacodynamic modeling of preclinical and clinical data of the oral MET inhibitor tepotinib to determine the recommended phase II dose	22
PBPK modeling to predict drug‐drug interactions of ivosidenib as a perpetrator in cancer patients and qualification of the Simcyp platform for CYP3A4 induction	21
PBPK Model of Coproporphyrin I: Evaluation of the Impact of SLCO1B1 Genotype, Ethnicity, and Sex on its Inter‐Individual Variability	21
Heterogeneous treatment effect analysis based on machine‐learning methodology	21
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	19
Hallmarks of neurodegenerative disease: A systems pharmacology perspective	19
Investigational Treatments for COVID‐19 may Increase Ventricular Arrhythmia Risk Through Drug Interactions	19
Prediction of overall survival in patients across solid tumors following atezolizumab treatments: A tumor growth inhibition–overall survival modeling framework	19

Population pharmacokinetic analysis of ulotaront in subjects with schizophrenia	19
Machine learning algorithms to estimate everolimus exposure trained on simulated and patient pharmacokinetic profiles	18
Berkeley Madonna Version 10–A simulation package for solving mathematical models	18
Evaluation framework for systems models	18
Exposure–safety analysis of QTc interval and transaminase levels following bedaquiline administration in patients with drug‐resistant tuberculosis	18
Prediction of CYP‐mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator	17
Physiologically‐based pharmacokinetic modeling of dextromethorphan to investigate interindividual variability within CYP2D6 activity score groups	17
Assessing the predictive performance of population pharmacokinetic models for intravenous polymyxin B in critically ill patients	17
Development of a model‐based clinical trial simulation platform to optimize the design of clinical trials for Duchenne muscular dystrophy	17
A Prototype QSP Model of the Immune Response to SARS‐CoV‐2 for Community Development	17
Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary	17
Network model‐based screen for FDA‐approved drugs affecting cardiac fibrosis	17
Comprehensive PBPK model to predict drug interaction potential of Zanubrutinib as a victim or perpetrator	16
Application of Machine Learning for Tumor Growth Inhibition – Overall Survival Modeling Platform	16
Physiologically‐Based Pharmacokinetic Modelling of Creatinine‐Drug Interactions in the Chronic Kidney Disease Population	16
Efficient and relevant stepwise covariate model building for pharmacometrics	16
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	16
Examination of Metoprolol Pharmacokinetics and Pharmacodynamics Across CYP2D6 Genotype‐Derived Activity Scores	16
Precision dosing of intravenous busulfan in pediatric hematopoietic stem cell transplantation: Results from a multicenter population pharmacokinetic study	16
Model‐Informed Pediatric Dose Selection for Dapagliflozin by Incorporating Developmental Changes	15
Population pharmacokinetics of letermovir following oral and intravenous administration in healthy participants and allogeneic hematopoietic cell transplantation recipients	15
Predicting disease activity in patients with multiple sclerosis: An explainable machine‐learning approach in the Mavenclad trials	15
Application of quantitative systems pharmacology to guide the optimal dosing of COVID‐19 vaccines	15
Pharmacometric modeling and machine learning analyses of prognostic and predictive factors in the JAVELIN Gastric 100 phase III trial of avelumab	15
Introduction of an artificial neural network–based method for concentration‐time predictions	15
Brigatinib Dose Rationale in Anaplastic Lymphoma Kinase–Positive Non‐Small Cell Lung Cancer: Exposure–Response Analyses of Pivotal ALTA Study	15
Physiologically‐based pharmacokinetic modeling to evaluate in vitro‐to‐in vivo extrapolation for intestinal P‐glycoprotein inhibition	14
Network module‐based drug repositioning for pulmonary arterial hypertension	14
Population pharmacokinetic‐pharmacodynamic analyses of amyloid positron emission tomography and plasma biomarkers for lecanemab in subjects with early Alzheimer's disease	14
Easy and reliable maximum a posteriori Bayesian estimation of pharmacokinetic parameters with the open‐source R package mapbayr	14
Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate	14
SAMBA: A novel method for fast automatic model building in nonlinear mixed‐effects models	14
The potential and pitfalls of artificial intelligence in clinical pharmacology	13
Data‐driven personalization of a physiologically based pharmacokinetic model for caffeine: A systematic assessment	13
Physiologically‐Based Pharmacokinetic Modeling for the Prediction of a Drug–Drug Interaction of Combined Effects on P‐glycoprotein and Cytochrome P450 3A	13
Population pharmacokinetics of favipiravir in patients with COVID‐19	13
Population pharmacokinetic model with time‐varying clearance for lorlatinib using pooled data from patients with non‐small cell lung cancer and healthy participants	13
Multi‐model averaging improves the performance of model‐guided infliximab dosing in patients with inflammatory bowel diseases	13
Multistate model for pharmacometric analyses of overall survival in HER2‐negative breast cancer patients treated with docetaxel	13
Deep compartment models: A deep learning approach for the reliable prediction of time‐series data in pharmacokinetic modeling	13
Unraveling pleiotropic effects of rifampicin by using physiologically based pharmacokinetic modeling: Assessing the induction magnitude of P‐glycoprotein–cytochrome P450 3A4 dual substrates	12
Evaluation of covariate effects using forest plots and introduction to the coveffectsplot R package	12
Quantitative systems pharmacology in neuroscience: Novel methodologies and technologies	12
Quantitative Assessment of Levonorgestrel Binding Partner Interplay and Drug‐Drug Interactions Using Physiologically Based Pharmacokinetic Modeling	12
Population pharmacokinetic modeling of GS‐441524, the active metabolite of remdesivir, in Japanese COVID‐19 patients with renal dysfunction	12
Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin	12
A continued learning approach for model‐informed precision dosing: Updating models in clinical practice	12
Stable warfarin dose prediction in sub‐Saharan African patients: A machine‐learning approach and external validation of a clinical dose–initiation algorithm	11
Evaluation of machine learning methods for covariate data imputation in pharmacometrics	11
Population pharmacokinetics of belantamab mafodotin, a BCMA‐targeting agent in patients with relapsed/refractory multiple myeloma	11

Application of SHAP values for inferring the optimal functional form of covariates in pharmacokinetic modeling	11
Comparing the applications of machine learning, PBPK, and population pharmacokinetic models in pharmacokinetic drug–drug interaction prediction	11
Population pharmacokinetic modeling and simulation to support qualification of pyridoxic acid as endogenous biomarker of OAT1/3 renal transporters	11
Estimating fetal exposure to the P‐gp substrates, corticosteroids, by PBPK modeling to inform prevention of neonatal respiratory distress syndrome	11
Pharmacometrics meets statistics—A synergy for modern drug development	11
Erdafitinib’s effect on serum phosphate justifies its pharmacodynamically guided dosing in patients with cancer	11
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
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	10
Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease	10
Population PBPK modeling using parametric and nonparametric methods of the Simcyp Simulator, and Bayesian samplers	10
Physiologically‐based pharmacokinetic modeling to predict CYP3A4‐mediated drug‐drug interactions of finerenone	10
Mechanistically modeling peripheral cytokine dynamics following bispecific dosing in solid tumors	10
A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development	10
Modeling is data driven: Use it for successful virtual patient generation	10
Physiologically‐based pharmacokinetic modeling of oxcarbazepine and levetiracetam during adjunctive antiepileptic therapy in children and adolescents	10
Cluster Gauss‐Newton method analyses of PBPK model parameter combinations of coproporphyrin‐I based on OATP1B‐mediated rifampicin interaction studies	10
Consistent methods for fat‐free mass, creatinine clearance, and glomerular filtration rate to describe renal function from neonates to adults	10
Prediction of cytochromes P450 3A and 2C19 modulation by both inflammation and drug interactions using physiologically based pharmacokinetics	10
An introduction to the full random effects model	10
Advancing drug safety science by integrating molecular knowledge with post‐marketing adverse event reports	10
Examination of Physiologically‐Based Pharmacokinetic Models of Rosuvastatin	10
Conditional distribution modeling as an alternative method for covariates simulation: Comparison with joint multivariate normal and bootstrap techniques	10
Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework	10
Quantitative systems pharmacology model for Alzheimer’s disease to predict the effect of aducanumab on brain amyloid	10
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	10
PK/PD modeling analysis for dosing regimen selection of isatuximab as single agent and in combination therapy in patients with multiple myeloma	10
Cross‐company collaboration to leverage analytics for clinical quality and accelerate drug development: The IMPALA industry group	10
Virtual clinical trial simulations for a novel KRAS^G12C inhibitor (ASP2453) in non‐small cell lung cancer	9
A framework to guide dose & regimen strategy for clinical drug development	9
A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development	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
An introduction to causal inference for pharmacometricians	9
Pharm‐AutoML: An open‐source, end‐to‐end automated machine learning package for clinical outcome prediction	9
Prediction of the drug–drug interaction potential of the α1‐acid glycoprotein bound, CYP3A4/CYP2C9 metabolized oncology drug, erdafitinib	9
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations	9
Population pharmacokinetic and exposure–response analyses of intravenous and subcutaneous rituximab in patients with chronic lymphocytic leukemia	9
Tumor growth inhibition modeling of individual lesion dynamics and interorgan variability in HER2‐negative breast cancer patients treated with docetaxel	9
Beyond the single average tumor: Understanding IO combinations using a clinical QSP model that incorporates heterogeneity in patient response	8
Delineating gene–environment effects using virtual twins of patients treated with clozapine	8
Development and application of a pediatric mechanistic kidney model	8
Use of physiologically‐based pharmacokinetic modeling to inform dosing of the opioid analgesics fentanyl and methadone in children with obesity	8
Development of physiologically‐based pharmacokinetic models for standard of care and newer tuberculosis drugs	8
Population pharmacokinetic modeling of molibresib and its active metabolites in patients with solid tumors: A semimechanistic autoinduction model	8
Population pharmacokinetic analysis of dupilumab in adult and adolescent patients with asthma	8
Physiologically‐based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate	8
Oncolytic viral kinetics mechanistic modeling of Talimogene Laherparepvec (T‐VEC) a first‐in‐class oncolytic viral therapy in patients with advanced melanoma	8
Detecting placebo and drug effects on Parkinson's disease symptoms by longitudinal item‐score models	8
Physiologically‐based pharmacokinetic modeling to predict drug interactions of lemborexant with CYP3A inhibitors	8
Finding the right hazard function for time‐to‐event modeling: A tutorial and Shiny application	8
Evaluation of drug–drug interaction potential for pemigatinib using physiologically based pharmacokinetic modeling	8
Optimized sampling to estimate vancomycin drug exposure: Comparison of pharmacometric and equation‐based approaches in a simulation‐estimation study	8
Estimands—What they are and why they are important for pharmacometricians	8
Physiologically based pharmacokinetic modeling of levetiracetam to predict the exposure in hepatic and renal impairment and elderly populations	8
A combined physiologically‐based pharmacokinetic and quantitative systems pharmacology model for modeling amyloid aggregation in Alzheimer's disease	8
A quantitative systems pharmacology approach to support mRNA vaccine development and optimization	8
Population pharmacokinetic analysis of rivaroxaban in children and comparison to prospective physiologically‐based pharmacokinetic predictions	8
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	8
Quantitative systems pharmacology model of the amyloid pathway in Alzheimer's disease: Insights into the therapeutic mechanisms of clinical candidates	8
Elevated acute phase proteins affect pharmacokinetics in COVID‐19 trials: Lessons from the CounterCOVID ‐ imatinib study	8
Pretomanid dose selection for pulmonary tuberculosis: An application of multi‐objective optimization to dosage regimen design	7
Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y₁₂ receptor between selatogrel and oral P2Y₁₂ antagonists	7
Application of longitudinal item response theory models to modeling Parkinson’s disease progression	7
Quantitative systems pharmacology of the eye: Tools and data for ocular QSP	7
Model‐informed target identification and validation through combining quantitative systems pharmacology with network‐based analysis	7
Dose/exposure–response modeling in dose titration trials: Overcoming the titration paradox	7
End‐to‐end application of model‐informed drug development for ertugliflozin, a novel sodium‐glucose cotransporter 2 inhibitor	7
SARS‐CoV‐2 viral dynamic modeling to inform model selection and timing and efficacy of antiviral therapy	7
Population pharmacokinetic model for once‐daily intravenous busulfan in pediatric subjects describing time‐associated clearance	7
Minimal physiologically‐based hybrid model of pharmacokinetics in pregnant women: Application to antenatal corticosteroids	7
Population repeated time‐to‐event analysis of exacerbations in asthma patients: A novel approach for predicting asthma exacerbations based on biomarkers, spirometry, and diaries/questionnaires	7
Application of a dual mechanistic approach to support bilastine dose selection for older adults	7
Physiologically‐based pharmacokinetic modeling of remdesivir and its metabolites in pregnant women with COVID‐19	7
Verifying in vitro‐determined enzyme contributions to cannabidiol clearance for exposure predictions in human through physiologically‐based pharmacokinetic modeling	7
Model enhanced reinforcement learning to enable precision dosing: A theoretical case study with dosing of propofol	7
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview	7
Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop	7
Model‐based prediction of effective target exposure for MEN1611 in combination with trastuzumab in HER2‐positive advanced or metastatic breast cancer patients	7
Mechanistic modeling of generic orally inhaled drug products: A workshop summary report	7
Performance of Cox proportional hazard models on recovering the ground truth of confounded exposure–response relationships for large‐molecule oncology drugs	6
Predicting the correct dose in children: Role of computational Pediatric Physiological‐based pharmacokinetics modeling tools	6

Pharmacokinetic‐pharmacodynamic modelling of the anti‐FcRn monoclonal antibody rozanolixizumab: Translation from preclinical stages to the clinic	6
Cytochrome P450 2D6 genotype–phenotype characterization through population pharmacokinetic modeling of tedatioxetine	6
An age‐dependent mathematical model of neurofilament trafficking in healthy conditions	6
A workflow for the joint modeling of longitudinal and event data in the development of therapeutics: Tools, statistical methods, and diagnostics	6
A quantitative approach to the choice of number of samples for percentile estimation in bootstrap and visual predictive check analyses	6
Flexible and efficient Bayesian pharmacometrics modeling using Stan and Torsten, Part I	6
Evaluating the performance of machine‐learning regression models for pharmacokinetic drug–drug interactions	6
Model‐informed drug development supporting the approval of the avelumab flat‐dose regimen in patients with advanced renal cell carcinoma	6
Artificial intelligence–guided precision treatment of chronic kidney disease–mineral bone disorder	6
Designing phase I oncology dose escalation using dose–exposure–toxicity models as a complementary approach to model‐based dose–toxicity models	6
Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery	6
Does the choice of applied physiologically‐based pharmacokinetics platform matter? A case study on simvastatin disposition and drug–drug interaction	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
R and nlmixr as a gateway between statistics and pharmacometrics	6
Predicting changes in the pharmacokinetics of CYP3A‐metabolized drugs in hepatic impairment and insights into factors driving these changes	6
Personalise vitamin D₃ using physiologically based pharmacokinetic modelling	6
Growth‐rate model predicts in vivo tumor response from in vitro data	6
Early predictions of response and survival from a tumor dynamics model in patients with recurrent, metastatic head and neck squamous cell carcinoma treated with immunotherapy	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
Synthetic Model Combination: A new machine‐learning method for pharmacometric model ensembling	6
Exposure–response analysis of efficacy and safety for pexidartinib in patients with tenosynovial giant cell tumor	6
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report	6
Population pharmacokinetics of mobocertinib in healthy volunteers and patients with non–small cell lung cancer	6
Population pharmacokinetic analysis for tisotumab vedotin in patients with locally advanced and/or metastatic solid tumors	6
CPT: Pharmacometrics & Systems Pharmacology – Inception, Maturation, and Future Vision	6
Clinical decision support for chemotherapy‐induced neutropenia using a hybrid pharmacodynamic/machine learning model	6
Sabatolimab (MBG453) model‐informed drug development for dose selection in patients with myelodysplastic syndrome/acute myeloid leukemia and solid tumors	6
Proarrhythmic risk assessment of drugs by dV_m/dt shapes using the convolutional neural network	6
Population pharmacokinetics of liposomal irinotecan in patients with cancer and exposure–safety analyses in patients with metastatic pancreatic cancer	6
Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report	6
Using physiologically‐based pharmacokinetic modeling for predicting the effects of hepatic impairment on the pharmacokinetics of olanzapine and samidorphan given as a combination tablet	6
Applying interpretable machine learning workflow to evaluate exposure–response relationships for large‐molecule oncology drugs	6
Development of a multiscale mechanistic modeling framework integrating differential cellular kinetics of CAR T‐cell subsets and immunophenotypes in cancer patients	6