title: Pharmaceutical toxicology: designing studies to reduce animal use, while maximizing human translation.
abstract: Evaluation of the safety of new chemicals and pharmaceuticals requires the combination of information from various sources (e.g. in vitro, in silico and in vivo) to provide an assessment of risk to human health and the environment. The authors have identified opportunities to maximize the predictivity of this information to humans while reducing animal use in four key areas; (i) accelerating the uptake of in vitro methods; (ii) incorporating the latest science into safety pharmacology assessments; (iii) optimizing rodent study design in biological development and (iv) consolidating approaches in developmental and reproductive toxicology. Through providing a forum for open discussion of novel proposals, reviewing current research and obtaining expert opinion in each of the four areas, the authors have developed recommendations on good practice and future strategy.
authors.affiliation: UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UK. Kathryn.Chapman@nc3rs.org.uk
authors.forename: Kathryn L
authors.initials: KL
authors.lastname: Chapman
authors.forename: Henry
authors.initials: H
authors.lastname: Holzgrefe
authors.forename: Lauren E
authors.initials: LE
authors.lastname: Black
authors.forename: Marilyn
authors.initials: M
authors.lastname: Brown
authors.forename: Gary
authors.initials: G
authors.lastname: Chellman
authors.forename: Christine
authors.initials: C
authors.lastname: Copeman
authors.forename: Jessica
authors.initials: J
authors.lastname: Couch
authors.forename: Stuart
authors.initials: S
authors.lastname: Creton
authors.forename: Sean
authors.initials: S
authors.lastname: Gehen
authors.forename: Alan
authors.initials: A
authors.lastname: Hoberman
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Kinter
authors.forename: Stephen
authors.initials: S
authors.lastname: Madden
authors.forename: Charles
authors.initials: C
authors.lastname: Mattis
authors.forename: Hugh A
authors.initials: HA
authors.lastname: Stemple
authors.forename: Stephen
authors.initials: S
authors.lastname: Wilson
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D012107:Research Design; D018570:Risk Assessment / Q000379:methods; D012377:Rodentia; D013045:Species Specificity; D014116:Toxicology / Q000379:methods*; D057170:Translational Research, Biomedical / Q000379:methods