title: Developmental toxicology: new directions workshop: refining testing strategies and study designs.
abstract: In April 2009, the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute's (HESI) Developmental and Reproductive Toxicology Technical Committee held a two-day workshop entitled "Developmental Toxicology-New Directions." The third session of the workshop focused on ways to refine animal studies to improve relevance and predictivity for human risk. The session included five presentations on: (1) considerations for refining developmental toxicology testing and data interpretation; (2) comparative embryology and considerations in study design and interpretation; (3) pharmacokinetic considerations in study design; (4) utility of genetically modified models for understanding mode-of-action; and (5) special considerations in reproductive testing for biologics. The presentations were followed by discussion by the presenters and attendees. Much of the discussion focused on aspects of refining current animal testing strategies, including use of toxicokinetic data, dose selection, tiered/triggered testing strategies, species selection, and use of alternative animal models. Another major area of discussion was use of non-animal-based testing paradigms, including how to define a "signal" or adverse effect, translating in vitro exposures to whole animal and human exposures, validation strategies, the need to bridge the existing gap between classical toxicology testing and risk assessment, and development of new technologies. Although there was general agreement among participants that the current testing strategy is effective, there was also consensus that traditional methods are resource-intensive and improved effectiveness of developmental toxicity testing to assess risks to human health is possible. This article provides a summary of the session's presentations and discussion and describes some key areas that warrant further consideration.
authors: Charles River Laboratories Preclinical Services, Horsham, Pennsylvania, USA. kimberly.brannen@crl.com
authors: Kimberly C
authors: KC
authors: Brannen
authors: Suzanne E
authors: SE
authors: Fenton
authors: Deborah K
authors: DK
authors: Hansen
authors: Wafa
authors: W
authors: Harrouk
authors: James H
authors: JH
authors: Kim
authors: Dana
authors: D
authors: Shuey
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D030801:Animals, Genetically Modified; D047109:Fetal Development / Q000187:drug effects; D006801:Humans; D023421:Models, Animal; D009152:Mutagenicity Tests / Q000379:methods; D012107:Research Design; D012306:Risk; D018570:Risk Assessment; D012449:Safety; D018675:Toxicity Tests / Q000379:methods*; D014116:Toxicology