Standardization and Substantial Equivalence of Components in Antiarrhythmic Device Systems: A Necessity to Avoid Regulatory Gridlock?

1995 ◽  
Vol 18 (4) ◽  
pp. 728-730
Author(s):  
SANJEEV SAKSENA ◽  
DANIEL E. NICKELSON
Keyword(s):  
Substantial Equivalence

Determination of theN-Glycosylation Patterns of Seed Proteins: Applications To Determine the Authenticity and Substantial Equivalence of Genetically Modified (GM) Crops

2011 ◽  
Vol 59 (16) ◽  
pp. 8779-8788 ◽  
Author(s):  
Justin T. Marsh ◽  
Theodora Tryfona ◽  
Stephen J. Powers ◽  
Elaine Stephens ◽  
Paul Dupree ◽  
...  
Keyword(s):  
Genetically Modified ◽  
Seed Proteins ◽  
Gm Crops ◽  
Substantial Equivalence

Nano-Based Food and Substantial Equivalence

2010 ◽  
Vol 2 (3) ◽  
pp. 46-54 ◽  
Author(s):  
Jenna Woodrow ◽  
Michael D. Mehta
Keyword(s):  
Decision Making ◽  
North America ◽  
Genetically Modified ◽  
Genetically Modified Foods ◽  
Substantial Equivalence ◽  
Category Mistake ◽  
Decision Making Tool

In recent years regulators have become sensitized to the fact that advances in nanotechnology challenge current regulatory approaches and capacities. Since many of these issues parallel earlier debates on genetically modified foods, it seems highly likely that similar decision-making tools and approaches will be used for governing nano-based food. A key decision-making tool used by regulators in North America and Europe involves application of the principle of substantial equivalence. In this paper, the authors argue that substantial equivalence is an inapt arbiter of equivalence for nano-based food, and that it incorporates a fundamental flaw in logic known as a category-mistake.

scholarly journals Covering Chemical Diversity of Genetically-Modified Tomatoes Using Metabolomics for Objective Substantial Equivalence Assessment

PLoS ONE ◽  
2011 ◽  
Vol 6 (2) ◽  
pp. e16989 ◽  
Author(s):  
Miyako Kusano ◽  
Henning Redestig ◽  
Tadayoshi Hirai ◽  
Akira Oikawa ◽  
Fumio Matsuda ◽  
...  
Keyword(s):  
Genetically Modified ◽  
Chemical Diversity ◽  
Substantial Equivalence

scholarly journals Recasting “Substantial Equivalence”:Transatlantic Governance of GM Food

2007 ◽  
Vol 32 (1) ◽  
pp. 26-64 ◽  
Author(s):  
Les Levidow ◽  
Joseph Murphy ◽  
Susan Carr
Keyword(s):  
Substantial Equivalence ◽  
Gm Food
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