Luke Fostvedt PK/PD Modeling of Abrocitinib Exposure and Peak Pruritus NRS Score
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Ahmed Salem A Full Bayesian Approach for Population Pharmacokinetic/Pharmacodynamic Modeling of Unfractionated Heparin in Pediatrics
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Concentration-QTcF Analysis of Quizartinib in Patients With Newly Diagnosed (ND) Acute Myeloid Leukemia (AML)
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Population Pharmacokinetics (PopPK) of Quizartinib and Its Active Metabolite AC886 in Patients With Newly Diagnosed (ND) Acute Myeloid Leukemia (AML)
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Development of a Physiologically Based Pharmacokinetic (PBPK) Model for Quizartinib and Evaluation of Drug-Drug Interaction (DDI) Risk as an Inhibitor of UDP-Glucuronosyltransferase 1A1 (UGT1A1)
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Population pharmacokinetic-pharmacodynamic model of long-acting granulocyte colony-stimulating factor, tripegfilgrastim, to the neutrophil response in healthy adults and pediatric patients after chemotherapy
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A Bayesian Population Pharmacokinetic Model for Imipenem and Relebactam to Support Selection of Optimal Dosing Regimens for Children of Less Than 2 Years of Age
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Anita Moein An Item Response Theory Model with Bounded Integer Subcomponents to Describe the Mayo Clinic Subscores in Patients with Ulcerative Colitis
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Dawoon Jung Pharmacokinetics of Plasma-derived Antithrombin III in Critically Ill Pediatric Patients Supported on Extracorporeal Membrane Oxygenation
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Shihao Hu Pharmacokinetics of the Engineered Fc-IL-15 Proteolytically Activated Cytokine Prodrug ASKG315
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Pharmacokinetic Modeling of Fentanyl Citrate and Norfentanyl in Calves Using a Nonlinear Mixed-Effects Approach
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A method to correct VPC bias due to non-random dropout via censored data addition using the MonolixSuite
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Florencio Serrano Castillo Investigating the potential impact of dosing variability to facilitate use of Romiplostin self-administration in adult patients with ITP
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Azar Shahraz Tumor Size Modeling Enables Selection of the Phase 3 Dose and Schedule for Savolitinib in Combination with Osimertinib
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Po-Wei Chen Comparison of Item Response Theory Modeling Frameworks between Two Patient-Reported Outcomes (PROs) in Migraine Prevention Drug Development
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Allison Dunn The Effect of Liver Dysfunction on the Pharmacokinetic Disposition of Belinostat and its Metabolites in Patients with Advanced Cancers
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Jia Zhou A Mechanism-based PK/PD Model to Predict Pharmacodynamics-Mediated Drug-Drug Interaction Propensity for Anti-FcRn Antibodies
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Yasong Lu A Comprehensive, Quantitative Evaluation of the Safety Profile of Dato-DXd, a TROP2-Directed Antibody-Drug Conjugate, in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
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Alexander Kulesza A disease drug trial model for multiple applications in the development of respiratory infection prophylaxis
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Jasmine Hughes One model to rule them all? Optimal model for model-informed precision dosing of vancomycin varies across healthcare providers
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Fernando Carreño Predictive Performance of Belantamab Mafodotin Population Pharmacokinetics Model in Earlier-Line Multiple Myeloma Patients
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Joan Korth-Bradley Two Population Pharmacokinetic Analyses of Somatrogon in Patients with Growth Hormone Deficiency
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Masato Fukae Landmark and longitudinal exposure-response analyses for multiple efficacy and safety endpoints to justify the clinical dose of valemetostat for adult T-cell leukemia/lymphoma
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Masato Fukae Simultaneous population pharmacokinetic analysis of total and unbound valemetostat in patients with non-Hodgkin lymphoma to quantify the effect of the binding protein, alpha 1-acid glycoprotein
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Hui Min Chan A tumor growth inhibition-overall survival (TGI-OS) model in unresectable hepatocellular carcinoma (HCC)
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Hui Min Chan Model estimates of baseline prognostic and treatment impacts on tumor growth inhibition (TGI) in non-small cell lung cancer (NSCLC)
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Shankar Lanke Update of population pharmacokinetics and exposure-response of olaparib incorporating data from OlympiA patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer
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Shankar Lanke Quantitative risk assessment enabled adavosertib monotherapy dose decision and mitigation of hematological toxicities and sepsis
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Hiroki Okada Population Pharmacokinetic Analysis of Rocatinlimab, an Anti-OX40 Monoclonal Antibody
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Hiroki Okada Population Pharmacokinetic-Pharmacodynamic Analysis of Rocatinlimab, an Anti-OX40 Monoclonal Antibody
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Tara Yang Mechanistic PK-PD Modeling and Simulation of Reversal of the Effects of Potent Opioids by Naloxone Auto-Injector (NAI) 10 mg Across a Range of Different Opioids and Doses
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Megan Melch Population Plasma Pharmacokinetic Analysis of Lumasiran in Pediatric and Adult Primary Hyperoxaluria Type 1 Patients
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Megan Melch Population Plasma Pharmacokinetic Analysis of Vutrisiran in Healthy Subjects and hATTR Amyloidosis Patients with Polyneuropathy
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Aram Oganesian Extending a Semi-Physiological PopPK Model of the Oral Fixed-Dose Combination of Cedazuridine with Decitabine in Myelodysplastic Syndrome Patients to Characterize an Acute Myeloid Leukemia Patient Population
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Aram Oganesian Semi-Physiological PopPK Model Refined with Phase 3 Oral Fixed-Dose Combination Data of Cedazuridine with Decitabine in Myelodysplastic Syndrome Patients
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Aram Oganesian A Population Pharmacokinetic Model of Tolinapant in Subjects with Advanced Solid Tumors and Lymphomas
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Elise Oh PKPD Modeling to Characterize Placebo and Treatment Effect of Omalizumab for Chronic Spontaneous Urticaria (CSU)
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Model-Informed Eteplirsen Dosing Regimen Extension Across Age Range for the DMD Population
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Congyu Zhang Across-species meta-analysis of betamethasone pharmacokinetics comparing compartmental and minimal PBPK models
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Denison Kuruvilla Prediction Of Overall Survival In Melanoma Patients Following Atezolizumab Treatment: A Tumor Growth Inhibition–Overall Survival Modeling Framework
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Kelly Mahar Population pharmacokinetics of daprodustat across five phase 2b/3 studies in chronic kidney disease (CKD) patients with anemia
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Kelly Mahar Innovative adaptive dose simulations in NONMEM to allow simulation-based model evaluation of titration-based dosing, applied to a population dose-hemoglobin model for daprodustat
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Kelly Mahar Population dose-Hgb modelling of daprodustat across five phase 3 studies in chronic kidney disease (CKD) patients with anemia
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Jeff Sachs Effective Visualizations Reloaded – Visually Assess and Communicate Model Fit for Pmx Models with Covariates Using VACHETTE (an Extension of V2ACHER)
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Krina Mehta Burosumab Treatment-Induced Increases in Serum Phosphate Provide Improvements in Patient Reported Outcomes in Adults with X-Linked Hypophosphatemia as Assessed with Graded Item Response Analysis
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Nicole Rivera Rosario Exposure-Response and Time-Course Analysis of Istradefylline (KW-6002) UPDRS II/III Using Graded Item Response Theory Approach
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PK/PD Characterization of INBRX-101, a Novel, Recombinant Alpha-1 Antitrypsin Fusion Protein, in Patients With Alpha-1 Antitrypsin Deficiency
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Jae Eun Ahn Population PK and PK/PD Analysis of Vupanorsen using Phase 1 and 2 Studies
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Conor O'Hanlon Consistent methods for Fat Free Mass, Creatinine Production Rate, Creatinine Clearance and Glomerular Filtration Rate for description of Renal Function in neonates to adults
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Naoki Kotani Use of Open Clinical Trial Data Source, Project Data Sphere (PDS), for Tumor Growth Inhibition - Overall Survival (TGI-OS) Modeling of First-Line Metastatic Castrate Resistant Prostate Cancer (1L mCRPC)
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Mutaz Jaber Simultaneous Exposure Analysis of Total and Unbound R- and S-methadone Concentrations
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Rena Byrne A Population Pharmacokinetic Model and Exposure-Response Model of Repeated Time Event (RTTE) to Justify a Dose Increase in Patients with Sickle Cell Disease
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Anitha Suram Population PK model of Avapritinib in patients with Gastrointestinal Stromal Tumors and Advanced Systemic Mastocytosis
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Shuang Liang Population pharmacokinetic and pharmacodynamic modelling of Dato-DXd in patients with advanced or metastatic NSCLC
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Joseph Raybon Disease Progression Modeling of MDS-UPDRS Composite Score to Inform Clinical Trial Design in Patients with Parkinson’s Disease
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Ka Lai Yee Item Response Theory Modeling for Detection of Cognitive Symptomatic Treatment Effects in Alzheimer’s Disease
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Satyawan Jadhav Population Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis of Vutrisiran in Healthy Subjects and hATTR Amyloidosis Patients with Polyneuropathy
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Population Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis of Lumasiran in Primary Hyperoxaluria Type I Patients = 6 Years of Age
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Population Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis of Lumasiran Effect on Spot Urinary Oxalate:Creatinine Ratio (UOx:Cr) in Pediatric (Infants to 18 Years of Age) and Adult Primary Hyperoxaluria Type 1 Patients
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Population Pharmacokinetic Model of Agalsidase-Migalastat Interaction: A Novel Mechanistic Model of Drug-Drug Interaction Between a Therapeutic Protein and a Small Molecule
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Alex Yu Demonstrating Bioequivalence of Apalutamide when Administered in Applesauce versus Whole Tablets Using Clinical Trial Simulation
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Shyeilla Dhuria Model Informed Development of LRRK2 Inhibitor DNL201 in Parkinson’s Disease: A Population Pharmacokinetics/Pharmacodynamics Approach for Dose Selection with a Sustained Release (SR) Formulation
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Minhyung Lee Pharmacokinetic and Pharmacodynamic Modeling Analysis of Zectivimod in Healthy Volunteers
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Husain Attarwala Immunostimulatory/Immunodynamic Model of an mRNA-Based Vaccine Against Cytomegalovirus Infection to Guide Vaccine Dose Selection
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Rebecca Silvola Estimated neonatal gabapentin exposure through breast milk immediately postpartum using a population pharmacokinetic approach
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Hongtao Yu Population Pharmacokinetics of Cotadutide in Subjects with Type 2 Diabetes and NASH
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Population Pharmacokinetics (PK) of Efmarodocokin alfa (IL-22Fc)
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Pharmacodynamic Modeling of Regenerating Islet Protein 3A (Reg3A) in Subjects Treated With Efmarodocokin alfa (IL-22Fc)
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Nadia Noormohamed Title: A Tale of Two Methods: A Comparison of Stepwise Covariate Modeling (SCM) and Manual Covariate Modeling
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Polatuzumab Vedotin Population Pharmacokinetics (popPK) and Exposure-Response (ER) Analyses From the POLARIX Study in Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
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Population Pharmacokinetic Analysis of HSG4112, a Synthetic Glabridin Derivative, in Healthy Subjects
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Elacestrant Population Pharmacokinetic and Exposure-Response Modelling Analyses to Support Elacestrant Dose Recommendations in Metastatic Breast Cancer (mBC) patients
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Hardik Chandasana Population Pharmacokinetic Analyses of DOVATO (Dolutegravir/Lamivudine) Fixed-Dose Combination in HIV-Infected Patients
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Jessie Zhou Target-Mediated Drug Disposition (TMDD) Pharmacokinetic and Pharmacodynamic (PK/PD) Modeling of the Anti-FcRn Monoclonal Antibody Nipocalimab Administered to Healthy Subjects
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Integrating Operational Model of Agonist in Model-Based Meta-Analysis for Assessing Inhibition of Ovulation Rate by Different Progestins
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Amit Roy Population pharmacokinetics of mavacamten in adults with obstructive hypertrophic cardiomyopathy (HCM)
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Timothy Rumbell Constructing virtual cohorts that recreate data distributions using generative adversarial networks
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Biophysical simulation approach for dose escalation in Phase I clinical trials
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Pharmacodynamic Model of Slow Reversible Binding and its Applications in PK/PD modeling: Review and Tutorial
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Fan Wu Population pharmacokinetic modeling for CC-99282, a novel cereblon E3 ligase modulator (CELMoD) agent, in patients with relapsed or refractory non-Hodgkin lymphoma
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Sihem Bihorel (Ait-Oudhia) Population Analyses of Pharmacokinetics, Safety, and Efficacy of Sotatercept in Patients with Pulmonary Arterial Hypertension
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Shuhui Li Exploration the Potential Impact of Batch-to-Batch Variability of Inhalation Powder Drug Products on Pharmacokinetic Bioequivalence Study Power
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Shuhui Li Population Pharmacokinetic Modeling for Fluticasone Propionate and Salmeterol Xinafoate Inhalation Powder in a Bioequivalence Study
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Yali Liang Generalized Pharmacokinetic-Pharmacodynamic (PK-PD) Modeling and Simulation of Myelosuppression Following Combination Therapy of Lurbinectedin with Talazoparib
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Tina Checchio An Evaluation of the Methodology Employed during Generation of Simulation Datasets during Pharmacometric Modeling.
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Modeling and simulation to investigate dose titration regimen for mavacamten in adults with obstructive hypertrophic cardiomyopathy (HCM)
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Exposure-response modeling of mavacamten in adults with hypertrophic cardiomyopathy (HCM)
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wayne Lin Impact of Exposure Metric on Binary Endpoints in Exposure-Response Analyses
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Brian Jermain Development of Adaptive Dose Simulations Using R and mrgsolve to Improve Tolerability While Maximizing Dose Intensity in Oncology
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Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of Prasugrel in Healthy Male Volunteers
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Simulation Study to Explore Optimal Sampling Time for Therapeutic Drug Monitoring of Voriconazole
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Population Pharmacokinetics and Exposure-Efficacy Analyses of Pevonedistat, a NEDD8-Activating-Enzyme Inhibitor, in Patients with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myeloid Leukemia
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Development of a level A in vitro/in vivo correlation (IVIVC) using applications of the MonolixSuite
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Jace Nielsen Exposure-Response Analysis of Fezolinetant in Women with Vasomotor Symptoms Associated with Menopause
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Mario Nagase Population Pharmacokinetic Analysis of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients with a KRASG12C Mutation from Phase 1 and Phase 2 Studies
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Sibo Jiang Population pharmacokinetics of Elranatamab in patients with relapsed/refractory multiple myeloma from the Phase 1 ?rst-in-patient study (MagnetisMM-1)
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Sibo Jiang Exposure-efficacy analysis for Elranatamab in patients with relapsed/refractory multiple myeloma (RRMM) from the Phase 1 first-in-patient study (MagnetisMM-1)
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Chih-Wei Lin A Platform Model for Multiple Time-To-Event Endpoints in Oncology Clinical Trials
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Jagan Parepally Population pharmacokinetic analysis for pralsetinib in patients with RET-positive non-small-cell lung cancers (NSCLC) and RET-altered thyroid cancer
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Extension to CP-1 Compartmental Models to Explore Unique Patterns in Cancer Patients Supporting Prediction of OATP1B1 Inhibition
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Wenlian Qiao A computational model leveraging natural history study data to quantify drug efficacy in achondroplasia
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Zheng Lu Pharmacometric analysis to support a higher recommended dose for trastuzumab deruxtecan (T-DXd) in the treatment of Western patients with metastatic gastric cancer (GC) versus breast cancer (BC)
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Zheng Lu Bridging an Asian population receiving third line-or-later treatment of trastuzumab deruxtecan (T-DXd) to a Western population receiving second-line treatment in metastatic gastric cancer (GC) using a modeling and simulation framework
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ANITHA SARAVANAKUMAR Population PKPD Modeling to Predict TAK-500 TMDD profiles in humans to enable first-in-human starting dose selection
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