Zobrazeno 1 - 8 of 8 pro vyhledávání: '"Kendy L. Keatley"'
1
Good Laboratory Practice in the Academic Setting: Fundamental Principles for Nonclinical Safety Assessment and GLP-Compliant Pathology Support When Developing Innovative Biomedical Products
Autor: Brad Bolon, Daniel J. Patrick, Kendy L Keatley, Kenneth A Schafer, Christopher Shilling, Wallace B. Baze
Publikováno v: ILAR Journal. 59:18-28
Development of new biomedical products necessitates nonclinical safety assessment in animals as a means of assessing potential risk to human patients. Pivotal nonclinical safety studies that support human clinical trials are performed according to Go
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2d48c046e7138bd6be5071de124e0eea
https://doi.org/10.1093/ilar/ily008
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2
A COMPARISON OF THE U.S. EPA FIFRA GLP STANDARDS WITH THE U.S. FDA GLP STANDARDS FOR NONCLINICAL LABORATORY STUDIES
Autor: Kendy L. Keatley
Publikováno v: Quality Assurance. 7:147-154
In the early 1980's both the Environmental Protection Agency and the Food and Drug Administration were receiving studies on the products that they regulate that were unscientifically sound, some even being fraudulent. Studies were being submitted tha
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::799f35d58f9a5973506647deb9b30ea8
https://doi.org/10.1080/105294100750035125
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5
Controversy over genetically modified organisms: the governing laws and regulations
Autor: Kendy L. Keatley
Publikováno v: Quality assurance (San Diego, Calif.). 8(1)
Genetically Modified Organisms (GMOs) are increasingly becoming a topic of controversy in the U.S. and abroad. The public is questioning their safety and wanting the products labeled as genetically modified. There are other concerns from some of the
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0bbfa96729ca3fdec7d73478290c588d
https://pubmed.ncbi.nlm.nih.gov/11710306
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6
A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions
Autor: Kendy L. Keatley
Publikováno v: Quality assurance (San Diego, Calif.). 7(2)
Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::661464d97b1faa4c7dbcb59531c0a4db
https://pubmed.ncbi.nlm.nih.gov/10992873
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7
A review of the FDA draft guidance document for software validation: guidance for industry
Autor: Kendy L. Keatley
Publikováno v: Quality assurance (San Diego, Calif.). 7(1)
A Draft Guidance Document (Version 1.1) was issued by the United States Food and Drug Administration (FDA) to address the software validation requirement of the Quality System Regulation, 21 CFR Part 820, effective June 1, 1997. The guidance document
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0c684bdbd0aa80c9afcd36b99e004a45
https://pubmed.ncbi.nlm.nih.gov/10707376
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