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Testing strategies for embryo-fetal toxicity of human pharmaceuticals. Animal models vs. in vitro approaches : A workshop report |
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| Authors: | Jan Willem van der Laan Robert E. Chapin Bert Haenen Abigail C. Jacobs Aldert Piersma |
| Affiliation: | 1. Medicines Evaluation Board, The Netherlands;2. Developmental and Reproductive Toxicology Group, Pfizer Global R&D, Eastern Point Rd., Groton, CT 06340, USA;3. 3 D-PharmXchange, Maidstone 48a, 5026 SK Tilburg, The Netherlands;4. ONDIO, CDER, FDA, USA;5. Laboratory for Health Protection Research, National Institute for Public Health and Environment RIVM, The Netherlands;6. Institute for Risk assessment Sciences, University of Utrecht, Utrecht, The Netherlands |
| Abstract: | Reproductive toxicity testing is characterized by high animal use. For registration of pharmaceutical compounds, developmental toxicity studies are usually conducted in both rat and rabbits. Efforts have been underway for a long time to design alternatives to animal use. Implementation has lagged, partly because of uncertainties about the applicability domain of the alternatives. |
| Keywords: | ICH, International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use REACH, Registration, Evaluation, Authorisation and restriction of Chemicals (Regulation (EC) No. 1907/2006) EST, embryonic stem cell tests ECVAM, European Center for Validation of Alternative Methods EFD, embryofetal development DART, developmental and reproductive toxicity rWEC, rat whole embryo culture ESAC, ECVAM Scientific Advisory Committee ZEBET, Zentralstelle zur Erfassung und Bewertung von Ersatz &ndash und Ergä nzungsmethoden zum Tierversuch ZEC, zebrafish embryo culture EMA, European Medicines Agency CBG-MEB, Medicines Evaluation Board in the Netherlands FDA&ndash CDER, United States Food & Drug Administration&ndash Center for Drugs Evaluation and Research |
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