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Exploring the Definition of “Similar Toxicities”: Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species

ICH S6 (R1) states that safety evaluation of biotherapeutics should normally include 2 relevant species when available (i.e., a rodent and non-rodent species in which the test material is pharmacologically active), at least for short-term toxicology studies (generally supporting Phase I trials). For...

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Detalles Bibliográficos
Autores principales:	Prior, Helen, Clarke, David O, Jones, David, Salicru, Eleni, Schutten, Melissa M, Sewell, Fiona
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	SAGE Publications 2022
Materias:	Symposia Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152593/ https://www.ncbi.nlm.nih.gov/pubmed/35435047 http://dx.doi.org/10.1177/10915818221081439

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