Towards precision medicine

EA Ashley - Nature Reviews Genetics, 2016 - nature.com
There is great potential for genome sequencing to enhance patient care through improved
diagnostic sensitivity and more precise therapeutic targeting. To maximize this potential …

Omics-based strategies in precision medicine: toward a paradigm shift in inborn errors of metabolism investigations

A Tebani, C Afonso, S Marret, S Bekri - International journal of molecular …, 2016 - mdpi.com
The rise of technologies that simultaneously measure thousands of data points represents
the heart of systems biology. These technologies have had a huge impact on the discovery …

Role of artificial intelligence and machine learning in nanosafety

DA Winkler - Small, 2020 - Wiley Online Library
Robotics and automation provide potentially paradigm shifting improvements in the way
materials are synthesized and characterized, generating large, complex data sets that are …

[HTML][HTML] One in seven pathogenic variants can be challenging to detect by NGS: an analysis of 450,000 patients with implications for clinical sensitivity and genetic test …

SE Lincoln, T Hambuch, JM Zook, SL Bristow… - Genetics in …, 2021 - Elsevier
Purpose To evaluate the impact of technically challenging variants on the implementation,
validation, and diagnostic yield of commonly used clinical genetic tests. Such variants …

[HTML][HTML] Toward multimodal signal detection of adverse drug reactions

R Harpaz, W DuMouchel, M Schuemie… - Journal of biomedical …, 2017 - Elsevier
Objective Improving mechanisms to detect adverse drug reactions (ADRs) is key to
strengthening post-marketing drug safety surveillance. Signal detection is presently …

Regulatory science to 2025: an analysis of stakeholder responses to the European medicines agency's strategy

PA Hines, R Gonzalez-Quevedo, AIOM Lambert… - Frontiers in …, 2020 - frontiersin.org
The pace of innovation is accelerating, and so medicines regulators need to actively
innovate regulatory science to protect human and animal health. This requires consideration …

Transporters in regulatory science: Notable contributions from Dr. Giacomini in the past two decades

L Zhang, Q Liu, SM Huang, R Lionberger - Drug Metabolism and …, 2022 - ASPET
Transporters govern the access of molecules to cells or their exit from cells, thereby
controlling the overall distribution of drugs to their intracellular site of action. Clinically …

Clinical translation of the assets of biomedical engineering–a retrospective analysis with looks to the future

Y Ren, PH Fagette, CL Hall, H Broers… - Expert review of …, 2019 - Taylor & Francis
ABSTRACT Introduction: Biomedical-engineering (BME) plays a major role in modern
medicine. Many BME-based assets have been brought to clinical translation in the twentieth …

Regulatory science and innovation Programme for Europe (ReScIPE): a proposed model

PA Hines, RH Guy, A Brand… - British journal of …, 2020 - Wiley Online Library
Regulatory science underpins the objective evaluation of medicinal products. It is therefore
imperative that regulatory science and expertise remain at the cutting edge so that …

The need for global regulatory harmonization: a public health imperative

E Zerhouni, M Hamburg - Science translational medicine, 2016 - science.org
The need for global regulatory harmonization: A public health imperative | Science Translational
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