Realizing the promise of project optimus: challenges and emerging opportunities for dose optimization in oncology drug development
W Gao, J Liu, B Shtylla… - CPT …, 2024 - Wiley Online Library
Project Optimus is a US Food and Drug Administration Oncology Center of Excellence
initiative aimed at reforming the dose selection and optimization paradigm in oncology drug …
initiative aimed at reforming the dose selection and optimization paradigm in oncology drug …
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper
D Samineni, K Venkatakrishnan… - Clinical …, 2024 - Wiley Online Library
The landscape of oncology drug development has witnessed remarkable advancements
over the last few decades, significantly improving clinical outcomes and quality of life for …
over the last few decades, significantly improving clinical outcomes and quality of life for …
Machine learning for exposure-response analysis: methodological considerations and confirmation of their importance via computational experimentations
Exposure-response (ER) is a key aspect of pharmacometrics analysis that supports drug
dose selection. Currently, there is a lack of understanding of the technical considerations …
dose selection. Currently, there is a lack of understanding of the technical considerations …
Multi-output prediction of dose–response curves enables drug repositioning and biomarker discovery
Drug response prediction is hampered by uncertainty in the measures of response and
selection of doses. In this study, we propose a probabilistic multi-output model to …
selection of doses. In this study, we propose a probabilistic multi-output model to …
Machine Learning‐Based Quantification of Patient Factors Impacting Remission in Patients With Ulcerative Colitis: Insights from Etrolizumab Phase III Clinical Trials
Etrolizumab, an investigational anti‐β7 integrin monoclonal antibody, has undergone
evaluation for safety and efficacy in phase III clinical trials on patients with moderate to …
evaluation for safety and efficacy in phase III clinical trials on patients with moderate to …
Predicting survival and trial outcome in non-small cell lung cancer integrating tumor and blood markers kinetics with machine learning
S Benzekry, M Karlsen, C Bigarré, AE Kaoutari… - medRxiv, 2023 - medrxiv.org
Existing survival prediction models rely only on baseline or tumor kinetics data and lack
machine learning integration. We introduce a novel kinetics-machine learning (kML) model …
machine learning integration. We introduce a novel kinetics-machine learning (kML) model …