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Seminar: How to Screen for Arrhythmias in Safety Pharmacology...
 

SOT 2010, Booth # 601
 

Derek

 With 20 years of experience and expertise LAB Research Hungary can perform a full DEREK analysis and expert report. LAB Research has an extensive background knowledge and experience in the requirements for the regulatory authorities as well as screening and predictive toxicology.


    Key Functions
  • It is a high throughput screen for genotoxicity/mutagenicity.
  • It predicts whether a chemical will be a skin sensitizer.
  • It predicts whether a chemical will be carcinogenic.
  • It highlights potential toxicological hazards covering a wide range of endpoints from irritancy to hepatotoxicity.
  • Derek for Windows is an expert knowledge base system. (www.lhasalimited.org)
  • LAB Research uses DEREK and now offers this as a resource for the pharmaceutical and chemical industries.

    Services
  • Screening candidate molecules to identify those least likely to have toxicity issues
  • Evaluating leading candidate molecules, to help prioritise safety tests to the most likely risk of problems (“Cross The Biggest Hurdles First”, or “Fail Early–Fail Cheap”)
  • To know what organisations like the FDA or EPA may identify when you submit
  • Helping rebut questions from regulatory agencies
  • Evaluating the risks from intermediates and impurities, often avoiding the need for synthesis and toxicology testing of minor components of technical products
  • Identifying the potential risks of intermediates for the different synthetic routes, as part of the decision process for route selection
  • Troubleshooting -  to aid in the identification of the root cause for mutagenic or sensitisation issues in batches of final products
  • DEREK will play a major role in the REACH process, in the triage of molecules for priority testing, and as a screen to avoid direct testing.
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For more information, please email LAB Research Hungary : inquiry @ labresearch.hu (remove spaces)

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