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Be Alternative

In preclinical drug development, in vitro studies are establishing themselves in a more prominent position. Because of ethical considerations, an increasing number of in vivo tests have been replaced by in vitro experiments. These tests are recommended by organisations such as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and (draft) Test Guidelines are accepted or sent for consideration to the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA) and the Organization of Economic Cooperation and Development (OECD), which are all part of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH).

The National Institutes of Health (NIH) and other federal agencies are committed to the welfare of research animals. These animals are protected by law, regulations and policies to ensure that companies are sued as rarely as possible and with special care taken in order to ensure animals’ comfort. Alternative test methods are those that accomplish one or more of the three ‘Rs’:

  • Reducing the number of animals used in testing through improved science and experimental design
  • Refining experimental procedures so that animals experience less pain and distress
  • Replacing animals with non-animal systems where possible

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Natalie MGM Appels obtained her Masters degree in Biopharmaceutical Sciences from the University of Leiden in 1998. Her career as a research scientist began at the spin-off company ScreenTec BV currently known as Kiadis BV. She received her PhD from the Netherlands Cancer Institute. Since 2006, she has been employed by NOTOX BV as a Study Director in the In Vitro ADME section.

Ilona Verbaan-Giebelen obtained her Masters degree in Medical Biology from the Free University of Amsterdam in 1999. She has worked as a Research Technician at Organon NV and received her PhD from the Centre for Experimental and Molecular Medicine at the Academic Medical Centre in Amsterdam. She joined NOTOX BV in 2008 as Study Director, Genetic and In Vitro Toxicology.

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Natalie MGM Appels
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Ilona Verbaan-Giebelen
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