Regulatory acceptance of alternative methods to assess the toxicity of E&Ls
Updated: Sep 27, 2018
The state-of-the art in the use of alternative methods to assess the toxicity of E&Ls will be discussed in a lecture which will be presented by Ronald Brown, a Toxicologist of U.S. FDA, at the Extractables & Leachables Europe 2018 in London in November 2018.
I heard him in March 2018 at the SOT on the same topic. At that time he focused the attention on three particular types of E&Ls: E&Ls from phamaceutical packaging / impurities in drugs, E&Ls from food-contacting substances, E&Ls from medical device materials giving examples and references on existing guidelines and recent publications emphasizing the role of QSARs and read-across. It is exciting that the 3Rs concept is entering this new sector.
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