Assessing the performance of QSP models: biology as the driver for validation.

[1]  Fraser Cunningham,et al.  Mathematical Modeling of Complement Pathway Dynamics for Target Validation and Selection of Drug Modalities for Complement Therapies , 2022, Frontiers in Pharmacology.

[2]  P. Pathmanathan,et al.  Evaluation framework for systems models , 2021, CPT: pharmacometrics & systems pharmacology.

[3]  A. Nader,et al.  Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis , 2021, Clinical and translational science.

[4]  Justin C. Earp,et al.  FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective , 2021, The AAPS Journal.

[5]  M. Stumpf,et al.  Collocation based training of neural ordinary differential equations , 2021, Statistical applications in genetics and molecular biology.

[6]  Samy Bengio,et al.  Understanding deep learning (still) requires rethinking generalization , 2021, Commun. ACM.

[7]  A. Popel,et al.  Quantitative systems pharmacology model predictions for efficacy of atezolizumab and nab-paclitaxel in triple-negative breast cancer , 2021, Journal for ImmunoTherapy of Cancer.

[8]  A. Popel,et al.  Quantitative Systems Pharmacology Modeling of PBMC-Humanized Mouse to Facilitate Preclinical Immuno-oncology Drug Development. , 2020, ACS pharmacology & translational science.

[9]  David G Strauss,et al.  A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development , 2020, CPT: pharmacometrics & systems pharmacology.

[10]  K. Gadkar,et al.  Mitigating the risk of cytokine release syndrome in a Phase I trial of CD20/CD3 bispecific antibody mosunetuzumab in NHL: impact of translational system modeling , 2020, npj Systems Biology and Applications.

[11]  Andy Z. X. Zhu,et al.  Quantitative Systems Pharmacology Approaches for Immuno‐Oncology: Adding Virtual Patients to the Development Paradigm , 2020, Clinical pharmacology and therapeutics.

[12]  Nils Gessert,et al.  Skin lesion classification using ensembles of multi-resolution EfficientNets with meta data , 2019, MethodsX.

[13]  Bing Wang,et al.  A QSP Model for Predicting Clinical Responses to Monotherapy, Combination and Sequential Therapy Following CTLA-4, PD-1, and PD-L1 Checkpoint Blockade , 2019, Scientific Reports.

[14]  Craig J. Thalhauser,et al.  Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1 , 2019, The AAPS Journal.

[15]  Daniel Kaschek,et al.  Quantitative Systems Pharmacology: An Exemplar Model‐Building Workflow With Applications in Cardiovascular, Metabolic, and Oncology Drug Development , 2019, CPT: pharmacometrics & systems pharmacology.

[16]  P. H. van der Graaf,et al.  A Translational Quantitative Systems Pharmacology Model for CD3 Bispecific Molecules: Application to Quantify T Cell-Mediated Tumor Cell Killing by P-Cadherin LP DART® , 2019, The AAPS Journal.

[17]  Jason R. Chan,et al.  A Flexible Approach for Context‐Dependent Assessment of Quantitative Systems Pharmacology Models , 2019, CPT: pharmacometrics & systems pharmacology.

[18]  C. Ng,et al.  Quantitative Systems Pharmacology Model of Chimeric Antigen Receptor T‐Cell Therapy , 2019, Clinical and translational science.

[19]  Mikhail Belkin,et al.  Reconciling modern machine-learning practice and the classical bias–variance trade-off , 2018, Proceedings of the National Academy of Sciences.

[20]  A. Verstraete,et al.  Population pharmacokinetics and evaluation of the predictive performance of pharmacokinetic models in critically ill patients receiving continuous infusion meropenem: a comparison of eight pharmacokinetic models , 2018, The Journal of antimicrobial chemotherapy.

[21]  Neil Benson,et al.  Quantitative Systems Pharmacology Model for Alzheimer Disease Indicates Targeting Sphingolipid Dysregulation as Potential Treatment Option , 2018, CPT: pharmacometrics & systems pharmacology.

[22]  Daniel C. Kirouac,et al.  How Do We “Validate” a QSP Model? , 2018, CPT: pharmacometrics & systems pharmacology.

[23]  Kirill Peskov,et al.  Radiation and PD-(L)1 treatment combinations: immune response and dose optimization via a predictive systems model , 2018, Journal of Immunotherapy for Cancer.

[24]  T. Nicholas,et al.  A Translational Systems Pharmacology Model for Aβ Kinetics in Mouse, Monkey, and Human , 2017, CPT: pharmacometrics & systems pharmacology.

[25]  Craig J. Thalhauser,et al.  QSP Toolbox: Computational Implementation of Integrated Workflow Components for Deploying Multi-Scale Mechanistic Models , 2017, The AAPS Journal.

[26]  K. Gadkar,et al.  Clinical responses to ERK inhibition in BRAFV600E-mutant colorectal cancer predicted using a computational model , 2017, npj Systems Biology and Applications.

[27]  RJ Allen,et al.  Efficient Generation and Selection of Virtual Populations in Quantitative Systems Pharmacology Models , 2015, bioRxiv.

[28]  K Biliouris,et al.  MatVPC: A User-Friendly MATLAB-Based Tool for the Simulation and Evaluation of Systems Pharmacology Models , 2015, CPT: pharmacometrics & systems pharmacology.

[29]  John D. Davis,et al.  A Mechanistic Systems Pharmacology Model for Prediction of LDL Cholesterol Lowering by PCSK9 Antagonism in Human Dyslipidemic Populations , 2014, CPT: pharmacometrics & systems pharmacology.

[30]  P Vicini,et al.  A Mechanistic, Multiscale Mathematical Model of Immunogenicity for Therapeutic Proteins: Part 2—Model Applications , 2014, CPT: pharmacometrics & systems pharmacology.

[31]  P Vicini,et al.  A Mechanistic, Multiscale Mathematical Model of Immunogenicity for Therapeutic Proteins: Part 1—Theoretical Model , 2014, CPT: pharmacometrics & systems pharmacology.

[32]  Elias S. Manolakos,et al.  In silico modeling of the effects of alpha-synuclein oligomerization on dopaminergic neuronal homeostasis , 2014, BMC Systems Biology.

[33]  M. Hegen,et al.  A Multiscale Model of Interleukin-6–Mediated Immune Regulation in Crohn's Disease and Its Application in Drug Discovery and Development , 2014, CPT: pharmacometrics & systems pharmacology.

[34]  Johannes P. Schlöder,et al.  Replication Vesicles are Load- and Choke-Points in the Hepatitis C Virus Lifecycle , 2013, PLoS pathogens.

[35]  Fergal P. Casey,et al.  Alternate virtual populations elucidate the type I interferon signature predictive of the response to rituximab in rheumatoid arthritis , 2013, BMC Bioinformatics.

[36]  Trevor Hastie,et al.  An Introduction to Statistical Learning , 2013, Springer Texts in Statistics.

[37]  B. Hendriks.  Negative Modeling Results: A Dime a Dozen or a Stepping Stone to Scientific Discovery? , 2013, CPT: pharmacometrics & systems pharmacology.

[38]  S. Visser,et al.  Systems Pharmacology Modeling of Drug-Induced Modulation of Thyroid Hormones in Dogs and Translation to Human , 2013, Pharmaceutical Research.

[39]  Eric Bair,et al.  Cross-validation for nonlinear mixed effects models , 2013, Journal of Pharmacokinetics and Pharmacodynamics.

[40]  P. H. van der Graaf,et al.  Integrated Pharmacometrics and Systems Pharmacology Model-Based Analyses to Guide GnRH Receptor Modulator Development for Management of Endometriosis , 2012, CPT: pharmacometrics & systems pharmacology.

[41]  David J. Klinke,et al.  Integrating Epidemiological Data into a Mechanistic Model of Type 2 Diabetes: Validating the Prevalence of Virtual Patients , 2008, Annals of Biomedical Engineering.

[42]  S. Duffull,et al.  Selection and Qualification of Simplified QSP Models When Using Model Order Reduction Techniques , 2017, The AAPS Journal.