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Justification for species selection for pharmaceutical toxicity studies.

Helen Prior1, Richard Haworth2, Briony Labram1

  • 1National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), 215 Euston Rd, London, NW1 2BE, UK.

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Selecting appropriate mammalian species for pharmaceutical toxicity studies balances scientific, ethical, and practical factors. This ensures regulatory compliance and informs drug development decisions effectively.

Keywords:
3Rsdogdrug developmentminipignon-rodentratrodentsafety assessmenttoxicology

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Area of Science:

  • Pharmacology
  • Toxicology
  • Drug Development

Background:

  • Mammalian species are crucial for pharmaceutical safety data required for clinical development and regulatory approval.
  • International guidelines offer flexibility in species selection (rodent/non-rodent) based on drug modality and specific needs.
  • Species selection involves scientific, ethical, and practical considerations, with company preferences varying based on molecule characteristics and experience.

Purpose of the Study:

  • To summarize discussions on species selection for pharmaceutical toxicity studies presented at the 2019 British Toxicology Society Congress.
  • To review the use and justification of one or two species in regulatory toxicology studies.
  • To explore company perspectives on species selection for biologics and small molecules.

Main Methods:

  • Review of an international collaboration by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and the Association of British Pharmaceutical Industry (ABPI).
  • Presentation of company-specific processes for selecting toxicology species for biologics.
  • Justification of the minipig as a toxicology species for small molecules.

Main Results:

  • The NC3Rs/ABPI collaboration reviewed species usage and justifications in regulatory toxicology.
  • Pharmaceutical companies shared their methodologies for selecting species for biologics evaluation.
  • The minipig was presented as a suitable species for small molecule toxicity testing.

Conclusions:

  • Ensuring the use of appropriate animal species in toxicity studies is vital for meeting regulatory requirements.
  • Informed species selection provides maximum value for guiding project decisions in drug development.
  • Balancing scientific, ethical, and practical factors is key to optimal species selection.