In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products
Viceconti, Marco, Pappalardo, Francesco, Rodriguez, Blanca, Horner, Marc, Bischoff, Jeff, Musuamba Tshinanu, Flora·2021·Methods
Cited by (361)
Items 301–361 of 361
- Validating Physiologically‐Based Pharmacokinetic Models Using the Continuous Ranked Probability Score: Beyond Being Correct on AverageLaurens Sluijterman, Marjolein D. van Borselen, Rick Greupink, Joanna IntHout · 2026 · CPT Pharmacometrics & Systems Pharmacology
- In Silico Evaluation of Algorithm-Based Clinical Decision Support Systems Based on Care Pathway Simulation Models: Scoping ReviewMichael Dorosan, Ya-Lin Chen, Yan He, Qingyuan Zhuang, Shao Wei Lam · 2026 · JMIR AI
- Progress of computational biomechanical modelling for calcaneal fracture fixationDuo Wai‐Chi Wong, James Chung‐Wai Cheung, Lucci Lugee Liyeung, Esther Man‐Wai Chow, Winson Chiu-Chun Lee, Wenxin Niu, Ming Ni · 2026 · Biomedical Technology
- The customization paradox: Why geometric precision is no substitute for biological integration?Frank Traub, Beatrice Jung, Tilmann Busse, Eren Demir, Felix Wunderlich · 2026 · Exploration of BioMat-X
- New approaches in assessing potential proarrhythmic risk and cardiovascular safety during medicines development: opportunities for 3Rs applicationGema Mondéjar‐Parreño, Orla Moriarty, Stefano Ponzano, Eirini Kyriakopoulou, Sonja Beken, Enrico Tognana · 2026 · NAM journal.
- In silico trialsLuigi La Barbera, Linda Carpenedo · 2026 · Elsevier eBooks
- Advances in new approach methodologies for assessing ADME properties of nano-formulationsAishwarya Jain · 2026 · Xenobiotica
- Parameter Uncertainty in Multibody Models of the Natural Knee Joint: A Scoping ReviewMehran Hatamzadeh, Karolina Sowa, Raphaël Dumas, Adam Ciszkiewicz · 2026 · Biomechanics
- Automation is not yet credibility: on cohort realism, uncertainty propagation, and context-of-use validation in cardiac in silico trialsMarcio Madrid, Edil Argueta, Isaac Zablah · 2026 · Computer Methods and Programs in Biomedicine
- „Digital twins“ in der UroonkologieJohanna Smielowski, Maximilian Glienke, Sherif Mehralivand, Gregor Duwe, Felix K.‐H. Chun, Hendrik Borgmann, Magdalena Görtz · 2026 · Die Urologie
- Event-based fractional order control for multi-drug anesthesia systems: Improved performance with computational efficiencyErwin T. Hegedüs, Isabela Birs, Clara Mihaela Ionescu, Marcian D. Mihai, Cristina Ioana Muresan · 2026 · Biomedical Signal Processing and Control
- Longitudinal Tracking of Valve Regurgitation from Peripheral Photoplethysmography Using a 1D Hemodynamic Surrogate: a Joint MCMC-Kalman FrameworkKiran Bhattacharyya · 2026 · medRxiv
- Artificial intelligence-driven nanomaterials for tumor-targeted therapyZijian Liao, Huiting Liang, Feng Siman · 2026 · Journal of Pharmacy and Allied Medicine
- The Complex Relationship Between HDL/LDL Cholesterol, Stroke and Cardiovascular DiseaseMark Parker, Tanja Novakovic, Milica Krga Rastović, Vanesa Benković, Iñaki Gutiérrez‐Ibarluzea · 2026 · Healthcare
- Predicting mechanical failure in spinal metastases: from clinical scores to patient-specific biomechanical modelingLouis Anzalone, Hélène Follet, Alexandre Meynard, Cyrille B. Confavreux, Maria Rossella Fasinella, Évelyne Emery, David Mitton, Cedric Yves Barrey · 2026 · Neurochirurgie
- Numerical Inverse Design of Patient‐Specific Dental Implants: Accelerating FEA ‐Based Optimization via Evolutionary Neural SurrogatesMaría Prados‐Privado · 2026 · International Journal for Numerical Methods in Biomedical Engineering
- Aspiration to architecture: multi-omics, AI, digital twins, and blockchain for P4 medicineAlex E. Mohr, Anil Bajnath, Gail King, Thomas E. Ichim, Paniz Jasbi · 2026 · Journal of Translational Medicine
- Synthetic data generation: challenges and perspectives for gastrointestinal medicinePanagiota Gatoula, Dimitris K. Iakovidis, Dimitrios E. Diamantis, Vajira Lasantha Thambawita, Thomas de Lange, Anastasios Koulaouzidis · 2026 · Nature Reviews Gastroenterology & Hepatology
- A Systems Architecture for Data‐Constrained Environments: Leveraging the Astronaut Digital Twin to Improve Spaceflight Adaptation in HumansCaleb Schmidt, Steve Simske · 2026 · Insight
- A methodology for constructing and assessing a combined experimental and computational validation domain for patient-specific mandibular reconstructionCamilla Gironi, Federico Parisini, Gregorio Pisaneschi, Mattia Mele, Laura Cercenelli, Francesco Ceccariglia, Dario Croccolo, Achille Tarsitano, Emanuela Marcelli · 2026 · Journal of the mechanical behavior of biomedical materials/Journal of mechanical behavior of biomedical materials
- In silico optimization of regenerative cell therapy in the infarcted human ventricles to mitigate arrhythmic burdenLeto Luana Riebel, Zhinuo Jenny Wang, Xin Zhou, Lucas Arantes Berg, Cristian Trovato, Blanca Rodríguez · 2026 · Stem Cell Reports
- Artificial intelligence-driven virtual knockout in cancer research: Progress, challenges, and future perspectivesXiangyu Wang, Min Liu, Meng Jia, Quan Wang, Xiangwen Li, Qinbiao Zou, Xiuxiang Huang, Lina Zhang, Xinrong Lv, Jie Wang et al. · 2026 · The Innovation Oncology
- Digital Twins for Precision Pharmacology: An Integrative Review of Mechanistic Modeling, Virtual Patients, Pharmacokinetic Simulation, and Personalized TherapeuticsSantiago Morales, Laura Rojas, Camila Vega · 2026 · International Journal of Pharmaceutical and Phytopharmacological Research
- Digital Twins of Natural Product Pharmacology: Modeling Compound Exposure, Target Engagement, Pathway Response, Safety Risk, and Therapeutic OutcomesElena Petrova, Ivan Georgiev, Nikolay Stoyanov · 2026 · International Journal of Pharmaceutical and Phytopharmacological Research
- An Overview of the ASME V&V 40-2018 StandardMarc Horner · 2026 · Springer eBooks
- Implementation of a Model Credibility Framework: A Drug Development PerspectiveIne Skottheim Rusten, Flora Tshinanu Musuamba · 2026 · Springer eBooks
- Digital Twins in Healthcare: AI-Driven Virtual Patients Shaping the Future of Personalized MedicineNeelambari S, S Gejalakshmi, N. Harikrishnan, Jawaharsamuvel R, Mohammad Idrees H, Nantha Kumar Lingam, Sanjeev Barfa U M · 2026 · PAIN JOINTS SPINE
- Stabilizing DNA origami nanostructures for clinical translation through chemical and computational engineeringMelina Sarabandi, Vinit Kumar, Abazar Ghorbani, Carme Fàbrega, Natalia Navarro, Ramón Eritja, Moxian Chen · 2026 · Advanced Sensor and Energy Materials
- Importance of reproducibility in bone fracture prediction using numerical models for clinical applicationsDavid Mitton, Aurélie Levillain, Marc Gardegaront, Rémy Gauthier, Emile Saillard, Thomas Grenier, Jean‐Baptiste Pialat, Cyrille B. Confavreux, Hélène Follet · 2026 · Elsevier eBooks
- The skeletal connectome: From molecular circuitry to systemic network medicineWenqiang Liu, Dong Liu, Qianqian Liu, Yang Sun · 2026 · Pharmacological Reviews
- Future Directions and Emerging TechnologiesSimone Badal · 2026 · Springer eBooks
- From digital twins to clinically trustworthy twins: a clinical-claim-based validation framework for personalized digital healthAlexandre Vallée · 2026 · Frontiers in Digital Health
- What Machine Learning Adds to Pharmacometrics—and What Mechanistic Information It Risks RemovingYing Li, Hui Wang, Xiaoming Chen, Jun Zhang · 2025 · Pharmacophore
- When Does a Pharmaceutical Model Become a Digital Twin? An Umbrella Review across Pharmacology, Pharmaceutics, and Drug DeliveryT. Nkosi, L. Molefe, Sipho Dlamini, Ayanda Mokoena, Kabelo Ndlovu · 2026 · Pharmacophore
- Ensuring the quality of in silico evidence: application to medical devicesMarc Horner, Ani Amar, Alejandro Federico Frangi, Martha De Cunha Maluf-Burgman, Thierry Marchal, Francesco Pappalardo · 2026 · Briefings in Bioinformatics
- Counterfactual Dose Twins for Real-Time Precision Pharmacotherapy under Treatment Adaptation, Delayed Outcomes, Safety Constraints, and Incomplete Clinical ObservationRavi Kumar, Neha Sharma, Aniket Deshmukh, Sanjay Kulkarni, Arjun Nair · 2026 · International Journal Of Pharmaceutical Research And Allied Sciences
- Intravenous oxygen microbubbles during cardiopulmonary resuscitation: a mechanistic simulation studyHenrique Gomes Mendes, M. Zentar, Rafael Hortêncio Melo · 2026 · Resuscitation
- MicroRNA and Inflammatory Biomarker Signatures Associated With Neurological Outcome After Out‐Of‐Hospital Cardiac Arrest: The MiRacle StudyFrancisco Rafael Jimenez‐Trinidad, Eva Moreno-Monterde, Carlos Roca-Guerrero, Oriol De Diego, Teresa López‐Sobrino, Marc Izquierdo-Ribas, Pedro Luis Cepas Guillén, José María Moreno-Coca, Erwin Bechtold-Javier, Vanessa Hervàs et al. · 2026 · European Journal of Clinical Investigation
- Neurocommunication and Affective-State Analysis: A Physiological-Proxy-Gated Bimodal Framework for Masked-Distress ScenariosNayeli Bastidas-Benalcazar, Daniela Santos-Solís, Diego Cueva-Argudo, Enma Lechón-Santacruz, Diego A. Almeida-Galárraga, Paulo Navas, Henry Carvajal Mora, Nathaly Orozco-Garzón, Andrés Tirado-Espín · 2026 · Technologies
- Post-MI Remodeling Mechanics of Left Ventricle: Microstructure-Informed Models, Identifiability, and Uncertainty for Patient-Specific PredictionThanyani Pandelani, Fulufhelo James Nemavhola · 2026 · Bioengineering
- Beyond Structural Valve Degeneration: Rethinking Risk of Nitinol DurabilityFrancesco Nappi · 2026 · Heart Lung and Circulation
- In silico methodologies in computational medicine: From complex disease modeling to virtual clinicsMatteo Italia, José García Otero, Laura Azzimonti, José Manuel García‐Aznar, Fabio Dercole, Juan Belmonte-Beitia · 2026 · Biophysics Reviews
- A cellular Digital Twin framework for predictive and mechanistic modeling of drug responses in precision medicineDanishuddin, Md Azizul Haque, Geet Madhukar, Shawez Khan, Shahper Nazeer Khan, Jong-Joo Kim · 2026 · Biotechnology Advances
- Biomechanical modelling of the feto-placental and utero-placental circulations; where to from here?Sahan Jayatissa, Joanna L. James, Alys Rachel Clark · 2026 · Placenta
- AI-assisted design of green nanocarriers for targeted drug delivery in chronic woundsAishwarya Jain, Atish S. Mundada · 2026 · Next Nanotechnology
- Assessing the Credibility of Quantitative Information: A General FrameworkMarco Viceconti · 2026 · Annals of Biomedical Engineering
- Bioinformatics and artificial intelligence for the discovery of food-derived bioactive compounds with health applications: Current advances and future perspectivesDébora Fernandes Pinheiro, Jéssica Camile Favarin, Cássio Geremia Freire, Natan Veiga, Juliângela Mariane Schröeder Ribeiro dos Santos, Paula Carolina Kath, Vilmair Zancanaro, Letycia Vitória Corrêa, Gustavo Granemann Piola da Silva, Emyr Hiago Bellaver · 2026 · Current Pharmaceutical Analysis
- Artificial intelligence in toxicology: current advances, challenges and future directionsKamil Kuča, Siddhi Otari, Namrata Singh, Monita Gide, Rakesh Somani, Jiří Křenek, Dominik Palla, Eugenie Nepovimová · 2026 · Archives of Toxicology
- Explicit Mechanistic Operators in Predictive Virtual Cells: Evidence, Failure Modes, and a Minimum Falsification Framework for Single-Cell Perturbation PredictionMikołaj Stańczak, Sarfaraz K. Niazi · 2026 · Cells
- Design considerations for in silico drug discovery platform that can accelerate targeted drug repurposing: a focus on rare, neglected, and emerging diseasesAlan Talevi · 2026 · Expert Opinion on Drug Discovery
- Evolutionary Optimization of Extended Kalman Filter Hyperparameters for Adaptive Data-Driven ABP Prediction Framework Inspired by Cardiovascular Digital-Twin PrinciplesP J Suárez-Anta Rodríguez, Hugo G. Venegas, Alejandra Ibarra, Gabriel Martínez-Soltero, Eduardo Méndez Palos, Alma Y. Alanís · 2026 · Algorithms
- Stratified Safety Evaluation Framework for Natural Products Based on New Approach Methodologies in Integrative Medicine: A Narrative ReviewManzhu Cao, Xiaoyan Duan, Jie Li, Ziqi Zhou, Hongtao Jin · 2026 · Future Integrative Medicine
- Biomaterials and biomechanical design of distal weight-bearing implants: Computational modeling, biomaterial interfaces, and clinical translationMuntadher Saleh Mahdi, Ayad M. Takhakh, Mohamed Hamdy Doweidar · 2026 · Biomaterials Advances
- Rank Reduction Autoencoders for 3D Geometry-to-Stress Prediction on a Parametric Femur CohortRachèle Allena, Yves Rémond, Francisco Chinesta C, Sebastian Rodriguez, Jad Mounayer, Mohammad Javad Kazemzadeh‐Parsi, Amine Ammar, Mohammed El Fallaki Idrissi · 2026 · SSRN Electronic Journal
- Digitale Modelle und personalisierte Konzepte in der UroonkologieJohanna Smielowski, Maximilian Glienke, Sherif Mehralivand, Gregor Duwe, Felix K.‐H. Chun, Hendrik Borgmann, Magdalena Görtz · 2026 · Uro-News
- Host chromatin architecture in HPV-driven cervical cancer: molecular mechanisms and therapeutic resistanceKatsuyoshi Kumagai, Yasuhiro Suzuki, Kei Kitahara, Ayumi Chiba, Hiroaki Yajima · 2026 · Medical Oncology
- Digital twins in toxicology: Toward predictive, personalized and real-time risk assessmentKamil Kuča, Dominik Palla, Jiří Křenek, Eugenie Nepovimová · 2026 · Toxicology
- Overview of Regulatory Guidelines Related to Methods and Models for Small PopulationsLaurens Sluijterman, Letao Li, Kristin E. Karlsson, Vincent Damotte, Sarah Zohar, Kit C. B. Roes, Joanna IntHout · 2026 · Clinical Pharmacology & Therapeutics
- Predictive and mechanistic evaluation of ODE-informed machine learning for systemic lupus erythematosus disease-activity stratificationHao Li, Li-Yun Wu, Anzun Yang, Qi Wang, Qing Song, Yida Dai, Wei Zhou, Zeng Guo-yu, Shih-Pin Lee · 2026 · Computational Biology and Chemistry
- Material–interface trade-offs in biomaterial-based femoral head reconstruction for osteonecrosis: A finite element comparisonTianchen Zhang, Yuyang Zhai, Zilei Xia, Shanbin Zheng, Tianwei Xia, Chao Zhang, Yang Guo, Jirong Shen · 2026 · Materials & Design
- Stochastic modeling and control strategy for bone metastasis based on radiotherapyHassan Ranjbar, Afshin Babaei, Seddigheh Banihashemi, Ali Valinejad · 2026 · Results in Control and Optimization