Zobrazeno 1 - 10
of 13 571
pro vyhledávání: '"Regulatory"'
Publikováno v:
BMC Medical Ethics, Vol 22, Iss 1, Pp 1-9 (2021)
Abstract Background This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficie
Externí odkaz:
https://doaj.org/article/487a75286dbc4189ac639d68a855017f
Publikováno v:
BMC Medical Ethics, Vol 22, Iss 1, Pp 1-1 (2021)
An amendment to this paper has been published and can be accessed via the original article.
Externí odkaz:
https://doaj.org/article/fd61399e71b74a7b9622f9d3351a0d25
Autor:
National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Global Health, Committee on Stronger Food and Drug Regulatory Systems Abroad, Catherine E. Woteki, Gillian J. Buckley
Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a y
Autor:
National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Chemical Sciences and Technology, Board on Agriculture and Natural Resources, Board on Life Sciences, Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biot
Autor:
Karthik Lingineni, Varun Aggarwal, Juan Francisco Morales, Daniela J. Conrado, Diane Corey, Camille Vong, Jackson Burton, Jane Larkindale, Klaus Romero, Stephan Schmidt, Sarah Kim, the Cooperative International Neuromuscular Research Group investigators and Duchenne Regulatory Science Consortium members
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 11, Iss 3, Pp 318-332 (2022)
Abstract Early clinical trials of therapies to treat Duchenne muscular dystrophy (DMD), a fatal genetic X‐linked pediatric disease, have been designed based on the limited understanding of natural disease progression and variability in clinical mea
Externí odkaz:
https://doaj.org/article/9a5c7e29fe9d4a999c3b88d80d68d01e
Autor:
Eric Venner, Donna Muzny, Joshua D. Smith, Kimberly Walker, Cynthia L. Neben, Christina M. Lockwood, Phillip E. Empey, Ginger A. Metcalf, Chris Kachulis, The All of Us Research Program Regulatory Working Group, Sana Mian, Anjene Musick, Heidi L. Rehm, Steven Harrison, Stacey Gabriel, Richard A. Gibbs, Deborah Nickerson, Alicia Y. Zhou, Kimberly Doheny, Bradley Ozenberger, Scott E. Topper, Niall J. Lennon
Publikováno v:
Genome Medicine, Vol 14, Iss 1, Pp 1-13 (2022)
Abstract Background The All of Us Research Program (AoURP, “the program”) is an initiative, sponsored by the National Institutes of Health (NIH), that aims to enroll one million people (or more) across the USA. Through repeated engagement of part
Externí odkaz:
https://doaj.org/article/e910cd798cad40ff995d316fed013e1c
Publikováno v:
Blockchain in Healthcare Today (2022)
Topics such as supply chain, clinical trials and health data will be explored along with how blockchian can exist in harmony with GDPR.
Externí odkaz:
https://doaj.org/article/28d6ef9fe6fe415ab665e28333ee9048
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