Open AccessJustification for species selection for pharmaceutical toxicity studies
Author(s) -
Helen Prior,
Richard Haworth,
Briony Labram,
Ruth Roberts,
Alison Wolfreys,
Fiona Sewell
Publication year - 2020
Publication title -
toxicology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.709
H-Index - 31
eISSN - 2045-4538
pISSN - 2045-452X
DOI - 10.1093/toxres/tfaa081
Subject(s) - selection (genetic algorithm) , flexibility (engineering) , pharmaceutical industry , risk analysis (engineering) , biology , management science , business , pharmacology , computer science , engineering , economics , management , artificial intelligence
Toxicity studies using mammalian species are generally required to provide safety data to support clinical development and licencing registration for potential new pharmaceuticals. International regulatory guidelines outline recommendations for the order (rodent and/or non-rodent) and number of species, retaining flexibility for development of a diverse range of drug modalities in a manner relevant for each specific new medicine. Selection of the appropriate toxicology species involves consideration of scientific, ethical and practical factors, with individual companies likely having different perspectives and preferences regarding weighting of various aspects dependent upon molecule characteristics and previous experience of specific targets or molecule classes. This article summarizes presentations from a symposium at the 2019 Annual Congress of the British Toxicology Society on the topic of species selection for pharmaceutical toxicity studies. This symposium included an overview of results from a National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and Association of British Pharmaceutical Industry (ABPI) international collaboration that reviewed the use of one or two species in regulatory toxicology studies and justification for the species selected within each programme. Perspectives from two pharmaceutical companies described their processes for species selection for evaluation of biologics, and justification for selection of the minipig as a toxicological species for small molecules. This article summarizes discussions on the scientific justification and other considerations taken into account to ensure the most appropriate animal species are used for toxicity studies to meet regulatory requirements and to provide the most value for informing project decisions.