Matches in SemOpenAlex for { <https://semopenalex.org/work/W2085661640> ?p ?o ?g. }
- W2085661640 endingPage "315" @default.
- W2085661640 startingPage "309" @default.
- W2085661640 abstract "In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world.We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes.Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., good science). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP research.Public health decisions should be based on studies using appropriate protocols with appropriate controls and the most sensitive assays, not GLP. Relevant NIH-funded research using state-of-the-art techniques should play a prominent role in safety evaluations of chemicals." @default.
- W2085661640 created "2016-06-24" @default.
- W2085661640 creator A5002692454 @default.
- W2085661640 creator A5005000252 @default.
- W2085661640 creator A5006830779 @default.
- W2085661640 creator A5007699479 @default.
- W2085661640 creator A5011822802 @default.
- W2085661640 creator A5012489838 @default.
- W2085661640 creator A5015114638 @default.
- W2085661640 creator A5021877457 @default.
- W2085661640 creator A5022940952 @default.
- W2085661640 creator A5025595586 @default.
- W2085661640 creator A5027267648 @default.
- W2085661640 creator A5028510658 @default.
- W2085661640 creator A5031537044 @default.
- W2085661640 creator A5032055617 @default.
- W2085661640 creator A5032365502 @default.
- W2085661640 creator A5041175524 @default.
- W2085661640 creator A5041959228 @default.
- W2085661640 creator A5046991673 @default.
- W2085661640 creator A5048370252 @default.
- W2085661640 creator A5051514888 @default.
- W2085661640 creator A5056114543 @default.
- W2085661640 creator A5059585512 @default.
- W2085661640 creator A5061653624 @default.
- W2085661640 creator A5069992695 @default.
- W2085661640 creator A5073628561 @default.
- W2085661640 creator A5075010601 @default.
- W2085661640 creator A5077572681 @default.
- W2085661640 creator A5077633544 @default.
- W2085661640 creator A5078449684 @default.
- W2085661640 creator A5079437343 @default.
- W2085661640 creator A5082645966 @default.
- W2085661640 creator A5086001971 @default.
- W2085661640 creator A5087163334 @default.
- W2085661640 creator A5088849643 @default.
- W2085661640 creator A5089743628 @default.
- W2085661640 creator A5091100404 @default.
- W2085661640 date "2009-03-01" @default.
- W2085661640 modified "2023-10-16" @default.
- W2085661640 title "Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A" @default.
- W2085661640 cites W1581857624 @default.
- W2085661640 cites W1863544056 @default.
- W2085661640 cites W1966357969 @default.
- W2085661640 cites W1968614586 @default.
- W2085661640 cites W1970358298 @default.
- W2085661640 cites W1972022922 @default.
- W2085661640 cites W1975062839 @default.
- W2085661640 cites W1975204728 @default.
- W2085661640 cites W1986126010 @default.
- W2085661640 cites W1987516029 @default.
- W2085661640 cites W1991456147 @default.
- W2085661640 cites W1991891667 @default.
- W2085661640 cites W1994048261 @default.
- W2085661640 cites W1996193517 @default.
- W2085661640 cites W1996857104 @default.
- W2085661640 cites W2001085078 @default.
- W2085661640 cites W2001090572 @default.
- W2085661640 cites W2002135196 @default.
- W2085661640 cites W2007888807 @default.
- W2085661640 cites W2011868725 @default.
- W2085661640 cites W2022373675 @default.
- W2085661640 cites W2027533003 @default.
- W2085661640 cites W2028071281 @default.
- W2085661640 cites W2028787260 @default.
- W2085661640 cites W2039711181 @default.
- W2085661640 cites W2041002646 @default.
- W2085661640 cites W2041015819 @default.
- W2085661640 cites W2041554939 @default.
- W2085661640 cites W2044598637 @default.
- W2085661640 cites W2053343245 @default.
- W2085661640 cites W2057598257 @default.
- W2085661640 cites W2058856687 @default.
- W2085661640 cites W2062847019 @default.
- W2085661640 cites W2064854818 @default.
- W2085661640 cites W2065707820 @default.
- W2085661640 cites W2068908383 @default.
- W2085661640 cites W2073726509 @default.
- W2085661640 cites W2079724894 @default.
- W2085661640 cites W2080671154 @default.
- W2085661640 cites W2081491312 @default.
- W2085661640 cites W2095582725 @default.
- W2085661640 cites W2099008462 @default.
- W2085661640 cites W2099964971 @default.
- W2085661640 cites W2108900261 @default.
- W2085661640 cites W2109833994 @default.
- W2085661640 cites W2114729638 @default.
- W2085661640 cites W2128841974 @default.
- W2085661640 cites W2132457576 @default.
- W2085661640 cites W2135752342 @default.
- W2085661640 cites W2136016016 @default.
- W2085661640 cites W2136799713 @default.
- W2085661640 cites W2149930945 @default.
- W2085661640 cites W2149977703 @default.
- W2085661640 cites W2165471176 @default.
- W2085661640 cites W2327758174 @default.
- W2085661640 cites W2475926748 @default.
- W2085661640 cites W1625215485 @default.