TY - JOUR
KW - Animal Testing Alternatives
KW - Drug Evaluation, Preclinical
KW - Humans
KW - Inventions
KW - Patient Safety
AU - Elizabeth J. Baker
AU - Nancy A. Beck
AU - Ellen L. Berg
AU - Helene D. Clayton-Jeter
AU - P. Charukeshi Chandrasekera
AU - J. Lowry Curley
AU - Bruce A. Donzanti
AU - Lorna C. Ewart
AU - Jane M. Gunther
AU - J. Gerry Kenna
AU - Edward L. LeCluyse
AU - Michael N. Liebman
AU - Catherine L. Pugh
AU - Paul B. Watkins
AU - Kristie M. Sullivan
AB - 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.
BT - Drug Discovery Today
DA - 2019-02
DO - 10.1016/j.drudis.2018.11.011
IS - 2
LA - eng
N2 - 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.
PY - 2019
SP - 624
EP - 628
T2 - Drug Discovery Today
TI - Advancing nonclinical innovation and safety in pharmaceutical testing
VL - 24
SN - 1878-5832
ER -