TY - JOUR
T1 - Improving the drug development process by reducing the impact of adverse events
T2 - The case of cataracts considered
AU - Smith, Andrew F.
AU - Klotz, Alexander
AU - Wormstone, I. Michael
N1 - Publisher Copyright:
© 2016 Elsevier Ltd. All rights reserved.
PY - 2016/3
Y1 - 2016/3
N2 - Cataract was used as a model for the prevalence and economic impact of adverse events during the drug development process. Meta-analysis revealed a reported prevalence of cataract at 12.0% (1.0-43.3%), 3.8% (2.4-12.5%), 1.0% (0.0-8.1%), 1.7% (0.0-34.8%) and 3.8% (2.3-5.7%) of compounds in preclinical, Phase I, II, III and IV clinical trials, respectively. Utilising a human-based in vitro screening assay to predict cataractogenic potential in human could allow better selection of novel compounds at early-stage drug development. This could significantly reduce costs and ultimately increase the probability of a drug obtaining FDA approval for a clinical application.
AB - Cataract was used as a model for the prevalence and economic impact of adverse events during the drug development process. Meta-analysis revealed a reported prevalence of cataract at 12.0% (1.0-43.3%), 3.8% (2.4-12.5%), 1.0% (0.0-8.1%), 1.7% (0.0-34.8%) and 3.8% (2.3-5.7%) of compounds in preclinical, Phase I, II, III and IV clinical trials, respectively. Utilising a human-based in vitro screening assay to predict cataractogenic potential in human could allow better selection of novel compounds at early-stage drug development. This could significantly reduce costs and ultimately increase the probability of a drug obtaining FDA approval for a clinical application.
UR - http://www.scopus.com/inward/record.url?scp=84954350046&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2016.01.001
DO - 10.1016/j.drudis.2016.01.001
M3 - Review article
C2 - 26775751
AN - SCOPUS:84954350046
SN - 1359-6446
VL - 21
SP - 510
EP - 516
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 3
ER -