Results 291 to 300 of about 7,752,988 (327)

Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China

open access: yesEngineering, 2022
Regulatory science is a discipline that uses comprehensive methods of natural science, social science, and humanities to provide support for administrative decision-making through the development of new tools, standards, and approaches to assess the ...
Jun-zhi Wang
exaly   +2 more sources

Regulatory Science Approach in Pharmaceutical Development of Follow-On Versions of Non-Biological Complex Drug Products.

Journal of Pharmacy and Science, 2022
Scientific and technological breakthroughs in the field of Nanotechnology have been a driving force throughout the development and approval of Non-Biological Complex Drugs (NBCDs).
Daniela M. Zagalo   +2 more
semanticscholar   +1 more source

Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy

open access: yesFrontiers in Medicine, 2020
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 and consultation across all stakeholder groups.
Philip A Hines, Rosanne Janssens
exaly   +2 more sources

Rationality in Context: Regulatory Science and the Best Scientific Method

Science, Technology and Human Values, 2021
Is there such a thing as a “best scientific methodology” in regulatory (decision-oriented) science? By examining cases from varying regulatory processes, we argue that there is no best scientific method for generating decision-relevant data. In addition,
O. Todt, J. Luján
semanticscholar   +1 more source

“Invisible” Pollution? Knowledge Gridlock in Regulatory Science on Electronics Toxics

East Asian Science, Technology and Society: an International Journal, 2021
“High-tech” provides a cachet of futuristic wonders to localities claiming cutting-edge technological research and industrial innovation. But the high-tech electronic manufacturing processes release hundreds of chemicals and are no doubt ridden with ...
Wen-ling Tu
semanticscholar   +1 more source

A new European platform for advancing regulatory science research

Nature Reviews Drug Discovery
L. Barbier   +4 more
exaly   +2 more sources

Strategies for antimicrobial peptide coatings on medical devices: a review and regulatory science perspective

Critical Reviews in Biotechnology, 2020
Indwelling and implanted medical devices are subject to contamination by microbial pathogens during surgery, insertion or injection, and ongoing use, often resulting in severe nosocomial infections.
Mehdi Kazemzadeh-Narbat   +6 more
semanticscholar   +1 more source

Regulatory Science Perspective on the Analysis of Microplastics and Nanoplastics in Human Food.

Analytical Chemistry
Microplastics are increasingly reported, not only in the environment but also in a wide range of food commodities. While studies on microplastics in food abound, the current state of science is limited in its application to regulatory risk assessment by ...
T. Duncan   +3 more
semanticscholar   +1 more source

Standards of evidence and causality in regulatory science: Risk and benefit assessment.

Studies in history and philosophy of science, 2020
In this paper we analyze the Russo-Williamson Thesis (RWT) as a standard of evidence in regulatory science, in risk as well as benefit assessment. In our analysis we take account of the recent controversies that have taken place in regulation with ...
J. Luján, O. Todt
semanticscholar   +1 more source

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