@article{2576,
  keywords = {Animal Testing Alternatives, Drug Evaluation, Preclinical, Humans, Inventions, Patient Safety},
  author = {Elizabeth J. Baker and Nancy A. Beck and Ellen L. Berg and Helene D. Clayton-Jeter and P. Charukeshi Chandrasekera and J. Lowry Curley and Bruce A. Donzanti and Lorna C. Ewart and Jane M. Gunther and J. Gerry Kenna and Edward L. LeCluyse and Michael N. Liebman and Catherine L. Pugh and Paul B. Watkins and Kristie M. Sullivan},
  title = {Advancing nonclinical innovation and safety in pharmaceutical testing},
  abstract = {Nonclinical tests are considered crucial for understanding the safety of investigational medicines. However, the effective translation from nonclinical to human application is limited and must be improved. Drug development stakeholders are working to advance human-based in vitro and in silico methods that may be more predictive of human efficacy and safety in vivo because they enable scientists to model the direct interaction of drugs with human cells, tissues, and biological processes. Here, we recommend test-neutral regulations; increased funding for development and integration of human-based approaches; support for existing initiatives that advance human-based approaches; evaluation of new approaches using human data; establishment of guidelines for procuring human cells and tissues for research; and additional training and educational opportunities in human-based approaches.},
  year = {2019},
  journal = {Drug Discovery Today},
  volume = {24},
  pages = {624-628},
  month = {2019-02},
  issn = {1878-5832},
  doi = {10.1016/j.drudis.2018.11.011},
  language = {eng},
}