Distinguishing between expert and statistical systems for application under ICH M7

Regul Toxicol Pharmacol. 2017 Mar:84:124-130. doi: 10.1016/j.yrtph.2016.12.012. Epub 2017 Jan 3.

Authors

Chris Barber¹, Thierry Hanser², Philip Judson³, Richard Williams⁴

Affiliations

¹ Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds LS11 5PY, UK. Electronic address: chris.barber@lhasalimited.org.
² Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds LS11 5PY, UK. Electronic address: Thierry.Hanser@lhasalimited.org.
³ Heather Lea Cottage, Bland Hill, Norwood, Harrogate HG3 1TE, UK. Electronic address: Philip.Judson@blubberhouses.net.
⁴ Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds LS11 5PY, UK. Electronic address: Richard.Williams@lhasalimited.org.

PMID: 28057482
DOI: 10.1016/j.yrtph.2016.12.012

No abstract available

MeSH terms

Animals
Computer Simulation
Data Interpretation, Statistical
Drug Contamination / legislation & jurisprudence
Drug Contamination / statistics & numerical data*
Drug and Narcotic Control / legislation & jurisprudence
Drug and Narcotic Control / statistics & numerical data*
Expert Systems*
Humans
Models, Statistical*
Molecular Structure
Mutagenicity Tests / statistics & numerical data*
Mutagens / adverse effects*
Mutagens / analysis
Mutagens / chemistry
Mutagens / classification
Patient Safety / legislation & jurisprudence
Patient Safety / statistics & numerical data*
Policy Making
Quantitative Structure-Activity Relationship
Reproducibility of Results
Risk Assessment

Substances

Mutagens