Model‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12372
Time‐Varying Clearance and Impact of Disease State on the Pharmacokinetics of Avelumab in Merkel Cell Carcinoma and Urothelial Carcinoma
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12406
Best Practices to Maximize the Use and Reuse of Quantitative and Systems Pharmacology Models: Recommendations From the United Kingdom Quantitative and Systems Pharmacology Network
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12381
NONMEM Tutorial Part II: Estimation Methods and Advanced Examples
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12422
Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12479
Physiologically‐Based Pharmacokinetic Modeling vs. Allometric Scaling for the Prediction of Infliximab Pharmacokinetics in Pediatric Patients
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12456
Physiologically‐Based Pharmacokinetic Modeling Approach to Predict Rifampin‐Mediated Intestinal P‐Glycoprotein Induction
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12458
Expanded Physiologically‐Based Pharmacokinetic Model of Rifampicin for Predicting Interactions With Drugs and an Endogenous Biomarker via Complex Mechanisms Including Organic Anion Transporting Polypeptide 1B Induction
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12457
Reproducibility of Quantitative Systems Pharmacology Models: Current Challenges and Future Opportunities
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12390
Quantitative Systems Pharmacology for Neuroscience Drug Discovery and Development: Current Status, Opportunities, and Challenges
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12478
Applications of Quantitative Systems Pharmacology in Model‐Informed Drug Discovery: Perspective on Impact and Opportunities
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12463
Population Pharmacokinetics of Ipilimumab in Combination With Nivolumab in Patients With Advanced Solid Tumors
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12477
Physiologically‐Based Pharmacokinetic Modeling Analysis for Quantitative Prediction of Renal Transporter–Mediated Interactions Between Metformin and Cimetidine
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12398
A Theoretical Physiologically‐Based Pharmacokinetic Approach to Ascertain Covariates Explaining the Large Interpatient Variability in Tacrolimus Disposition
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12392
A Comprehensive Framework for Physiologically‐Based Pharmacokinetic Modeling in Matlab
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12399
Children Are Not Small Adults, but Can We Treat Them As Such?
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12366
A Survey of Software Tool Utilization and Capabilities for Quantitative Systems Pharmacology: What We Have and What We Need
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12373
Quantitative Systems Pharmacology and Empirical Models: Friends or Foes?
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12375
Current Scientific Considerations to Verify Physiologically‐Based Pharmacokinetic Models and Their Implications for Locally Acting Products
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12421
A Flexible Approach for Context‐Dependent Assessment of Quantitative Systems Pharmacology Models
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12409
Linking Tumor Growth Dynamics to Survival in Ipilimumab‐Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12454
In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12413
Concentration–QT Modeling Following Inhalation of the Novel Inhaled Phosphodiesterase‐4 Inhibitor CHF6001 in Healthy Volunteers Shows an Absence of QT Prolongation
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12405
Recommendations for the Design of Clinical Drug–Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically‐Based Pharmacokinetic Model
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12449
Pharmacokinetics of Capecitabine and Four Metabolites in a Heterogeneous Population of Cancer Patients: A Comprehensive Analysis
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12474
Evaluating the Role of Janus Kinase Pathways in Platelet Homeostasis Using a Systems Modeling Approach
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12419
Evaluation of QT Liability for PF‐05251749 in the Presence of Potential Circadian Rhythm Modification
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12483
Model Informed Drug Development and Regulation in China: Challenges and Opportunities
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12368
Open Source Pharmacokinetic/Pharmacodynamic Framework: Tutorial on the BioGears Engine
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12371
Development of a Parsimonious Design for Optimal Classification of Exclusive Breastfeeding
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12428
Iberoamerican Pharmacometrics Network Congress 2018 Report: Fostering Modeling and Simulation Approaches for Drug Development and Regulatory and Clinical Applications in Latin America
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12387
The Mathematical and Computational Sciences Special Interest Group of the International Society of Pharmacometrics
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12410
Exposure–Response‐Based Product Profile–Driven Clinical Utility Index for Ipatasertib Dose Selection in Prostate Cancer
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12394
Quantitative Systems Pharmacology Model of a Masked, Tumor‐Activated Antibody
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12448
Optimal Scheduling of Bevacizumab and Pemetrexed/Cisplatin Dosing in Non‐Small Cell Lung Cancer
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12415
Blood‐Based Biomarkers of Quinpirole Pharmacology: Cluster‐Based PK/PD and Metabolomics to Unravel the Underlying Dynamics in Rat Plasma and Brain
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12370
Industrialization of Quantitative Systems Pharmacology
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12427
Incorporating Placebo Response in Quantitative Systems Pharmacology Models
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12412
Probenecid‐Boosted Tenofovir: A Physiologically‐Based Pharmacokinetic Model‐Informed Strategy for On‐Demand HIV Preexposure Prophylaxis
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12481
Time‐to‐Event Modeling of Peripheral Neuropathy: Platform Analysis of Eight Valine‐Citrulline‐Monomethylauristatin E Antibody–Drug Conjugates
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12442
Could Postnatal Age–Related Uridine Diphosphate Glucuronic Acid Be a Rate‐Limiting Factor in the Metabolism of Morphine During the First Week of Life?
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12407
What Can Be Learned From Crowdsourced Population Asparagus Urinary Odor Kinetics?
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12401
Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12470
QSP and PBPK Modeling with mrgsolve: A Hands-on Tutorial.
来源期刊:CPT: pharmacometrics & systems pharmacologyDOI:10.1002/psp4.12467
Antibodies to Modulate Surface Receptor Systems Are Often Bivalent and Must Compete in a Two‐Dimensional Cell Contact Region
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12468
A Citrulline‐Based Translational Population System Toxicology Model for Gastrointestinal‐Related Adverse Events Associated With Anticancer Treatments
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12475
Causa Nostra: The Potentially Legitimate Business of Drawing Causal Inferences From Observational Data
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12395
ATLAS mPBPK: A MATLAB‐Based Tool for Modeling and Simulation of Minimal Physiologically‐Based Pharmacokinetic Models
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12441
Model‐Informed Assessment of Anti‐Infectives for Young Children in Low‐ and Middle‐Income Countries
来源期刊:CPT: Pharmacometrics & Systems PharmacologyDOI:10.1002/psp4.12393