title: Opportunities to minimise animal use in pharmaceutical regulatory general toxicology: a cross-company review.
abstract: Toxicity studies in animals are carried out to identify the intrinsic hazard of a substance to support risk assessment for humans. In order to identify opportunities to minimise animal use in regulatory toxicology studies, a review of current study designs was carried out. Pharmaceutical companies and contract research organisations in the UK shared data and experience of standard toxicology studies (ranging from one to nine months duration) in rodents and non-rodents; and carcinogenicity studies in the rat and mouse. The data show that variation in study designs was primarily due to (i) the number of animals used in the main study groups, (ii) the use of animals in toxicokinetic (TK) satellite groups, and (iii) the use of animals in off-treatment recovery groups. The information has been used to propose a series of experimental designs where small adjustments could reduce animal use in practice, while maintaining the scientific objectives.
authors.affiliation: GlaxoSmithKline, Park Road, Ware, Herts SG12 0DP, UK.
authors.forename: Susan S
authors.initials: SS
authors.lastname: Sparrow
authors.forename: Sally
authors.initials: S
authors.lastname: Robinson
authors.forename: Sue
authors.initials: S
authors.lastname: Bolam
authors.forename: Christopher
authors.initials: C
authors.lastname: Bruce
authors.forename: Andy
authors.initials: A
authors.lastname: Danks
authors.forename: David
authors.initials: D
authors.lastname: Everett
authors.forename: Stephen
authors.initials: S
authors.lastname: Fulcher
authors.forename: Rose E
authors.initials: RE
authors.lastname: Hill
authors.forename: Helen
authors.initials: H
authors.lastname: Palmer
authors.forename: Elspeth W
authors.initials: EW
authors.lastname: Scott
authors.forename: Kathryn L
authors.initials: KL
authors.lastname: Chapman
mesh_terms: D032761:Animal Experimentation; D023401:Animal Use Alternatives / Q000379:methods*; D000818:Animals; D004345:Drug Industry; D006801:Humans; D012107:Research Design; D018570:Risk Assessment / Q000379:methods; D018675:Toxicity Tests / Q000379:methods*