title: Is Science the Only Driver in Species Selection? An Internal Study to Evaluate Compound Requirements in the Minipig Compared to the Dog in Preclinical Studies.
abstract: Dogs have been often chosen as a nonrodent species for preclinical development of small molecule drugs mainly due to availability and relative ease of handling. Recently, focus has increased on the minipig as a potential alternative to the dog, based on either scientific rationale or public opinion concerns. There are, however, other factors influencing nonrodent choices, in particular drug amount and synthesis time, which differ between species and therefore may impact the milestones of a drug development program. To assess the magnitude of compound need, a retrospective internal survey was conducted on drug amounts used in dog studies which were translated into the requirements for minipigs. Compound need approximately doubles if minipigs are used. Costs of compound are accordingly higher, and synthesis times are slightly increased. In our company, the differences were not considered significant enough to preclude the use of minipigs if the later preclinical program might benefit from improved human risk prediction.
authors.affiliation: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, Ludwigshafen, Germany kai.schaefer@abbvie.com.
authors.forename: Kai
authors.initials: K
authors.lastname: Schaefer
authors.affiliation: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, Ludwigshafen, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Rensing
authors.affiliation: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, Ludwigshafen, Germany.
authors.forename: Heinz
authors.initials: H
authors.lastname: Hillen
authors.affiliation: AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: John E
authors.initials: JE
authors.lastname: Burkhardt
authors.affiliation: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, Ludwigshafen, Germany.
authors.forename: Paul-Georg
authors.initials: PG
authors.lastname: Germann
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000191:economics / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D004285:Dogs; D004353:Drug Evaluation, Preclinical / Q000191:economics / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D005260:Female; D008297:Male; D023421:Models, Animal; D012107:Research Design; D012189:Retrospective Studies; D013552:Swine; D013556:Swine, Miniature
keywords: drug development; minipig; nonrodent species; preclinical research & development; preclinical safety assessment/risk management; species selection; toxicity