Zobrazeno 1 - 10
of 30
pro vyhledávání: '"Rebecca Sheets"'
Autor:
Rebecca Sheets, Hye-Na Kang, Heidi Meyer, Ivana Knezevic, WHO informal consultation on development of guidelines for assuring the quality, safety, and efficacy of DNA vaccine
Publikováno v:
NPJ Vaccines
npj Vaccines, Vol 5, Iss 1, Pp 1-5 (2020)
npj Vaccines, Vol 5, Iss 1, Pp 1-5 (2020)
Consultations have been held to promote the revision of the WHO guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines adopted by the Expert Committee on Biological Standardization (ECBS) in 2005. The drivers for this r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2894a4d9810a316777da1fe19ad695cc
http://europepmc.org/articles/PMC7303131
http://europepmc.org/articles/PMC7303131
Publikováno v:
Biologicals. 44:37-50
An international workshop to discuss the role of Human Challenge Trials (HCT) in vaccine development was held in Strasbourg, France from 29 September to 1 October 2015. In addition to scientific presentations, several panel discussions focused on key
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7be483d9e5f1b17e3ac7715e08f9389d
https://doi.org/10.1016/j.biologicals.2015.10.003
https://doi.org/10.1016/j.biologicals.2015.10.003
Autor:
Rebecca Sheets
Public health and regulatory policy are a different avenue by which those in public health and those who are regulators can develop guidance, make recommendations, and make decisions to aid the public. Policy also serves to clarify how regulators thi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::957b23cf98f3bed316b624a07e5c3b81
https://doi.org/10.1016/b978-0-12-809290-3.00022-5
https://doi.org/10.1016/b978-0-12-809290-3.00022-5
Autor:
Rebecca Sheets
Preclinical safety evaluations are critical to the regulatory review process to give regulators data upon which to judge risk in their risk/benefit evaluations. Biologicals’ toxicology is distinct from drug toxicology; even though the methods used
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::27a2adae3cc63453df50be188a267e76
https://doi.org/10.1016/b978-0-12-809290-3.00011-0
https://doi.org/10.1016/b978-0-12-809290-3.00011-0
Autor:
Rebecca Sheets
A separate regulatory process from those already covered in this book, from the NRAs/NCLs and the agencies that regulated GMOs, is that of the regulation of the ethical conduct of clinical research. Institutional Review Boards (the U.S. term) or Inde
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6e4285c80b23ddf5468e59c226b6b9d7
https://doi.org/10.1016/b978-0-12-809290-3.00019-5
https://doi.org/10.1016/b978-0-12-809290-3.00019-5
Autor:
Rebecca Sheets
Many biotechnology products are made from or are themselves genetically modified (engineered) organisms (GMOs), which have been generated by recombinant DNA technology. Therefore, many of them are subject to an additional regulatory process beyond th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9202a083b6bbd8ac52851e54b5522db4
https://doi.org/10.1016/b978-0-12-809290-3.00013-4
https://doi.org/10.1016/b978-0-12-809290-3.00013-4
Autor:
Rebecca Sheets
Good “X” Practices delineate standards and norms of practices whereby biologics should be developed. These good practices have aspects in common, such as requirement for trained and qualified personnel, adequate facilities, prospectively planned
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::57e86c246433bf2fbf9b90e2daf495c6
https://doi.org/10.1016/b978-0-12-809290-3.00010-9
https://doi.org/10.1016/b978-0-12-809290-3.00010-9
Autor:
Rebecca Sheets
Product or Quality details are one of the three types of information that regulators require for decision-making. These details are derived through science-based methods and data are gathered as manufacturing processes are developed and optimized. Pr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ad333980a7be640169c5d823b419cb4e
https://doi.org/10.1016/b978-0-12-809290-3.00015-8
https://doi.org/10.1016/b978-0-12-809290-3.00015-8
Autor:
Rebecca Sheets, Ivana Knezevic
There have been efforts to harmonize, at an international level, regulatory requirements and expectations for the marketing authorization of medicinal products. This was for various purposes, including to streamline product development and to assure
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::22f21ce49f41a7f05da9ec4f8d2dad71
https://doi.org/10.1016/b978-0-12-809290-3.00003-1
https://doi.org/10.1016/b978-0-12-809290-3.00003-1