Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials
| Autor: | Diane Smith, Jessica Couch, Brian Short, David W. Brewster, David Jones, Ian Ragan, Emma Moore, Beatriz Silva Lima, Klaudia Hettinger, Petra M. Schmitt, Stephan Kopytek, Marilyn Hill, Rick Perry, Alan Broadmeadow, Alex Constan, David Jacobson-Kram, Markku Pasanen, Abby Jacobs, S.G. Moesgaard, Oliver Czupalla, Janet Clarke, Paul Brown, Leigh Ann Burns-Naas, Helga Lorenz, Matthias Festag, Kathryn Chapman, Lolke de Haan, Sally Robinson, Sue Sparrow, Andy Danks, Yvette van Bekkum, Paul Baldrick, Joseph J. DeGeorge, Fiona Sewell |
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| Rok vydání: | 2014 |
| Předmět: |
Process management
Time Factors Operations research International Cooperation Drug Evaluation Preclinical Toxicology 3Rs Reversibility Recovery Surveys and Questionnaires Dog Medicine Animals Humans Dosing Regulatory toxicology Reduction Rodent business.industry Primate Non-clinical General Medicine First in human Clinical trial Data sharing Drug development Research Design Repeat-dose studies Drug Design Models Animal business Inclusion (education) Recovery phase |
| Zdroj: | Regulatory Toxicology and Pharmacology. 70(1):413-429 |
| ISSN: | 0273-2300 |
| DOI: | 10.1016/j.yrtph.2014.07.018 |
| Popis: | An international expert group which includes 30 organisations (pharmaceutical companies, contract research organisations, academic institutions and regulatory bodies) has shared data on the use of recovery animals in the assessment of pharmaceutical safety for early development. These data have been used as an evidence-base to make recommendations on the inclusion of recovery animals in toxicology studies to achieve scientific objectives, while reducing animal use.Recovery animals are used in pharmaceutical development to provide information on the potential for a toxic effect to translate into long-term human risk. They are included on toxicology studies to assess whether effects observed during dosing persist or reverse once treatment ends.The group devised a questionnaire to collect information on the use of recovery animals in general regulatory toxicology studies to support first-in-human studies. Questions focused on study design, the rationale behind inclusion or exclusion and the impact this had on internal and regulatory decisions. Data on 137 compounds (including 53 biologicals and 78 small molecules) from 259 studies showed wide variation in where, when and why recovery animals were included. An analysis of individual study and programme design shows that there are opportunities to reduce the use of recovery animals without impacting drug development. |
| Databáze: | OpenAIRE |
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