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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Veröffentlicht in:	International Journal of Toxicology 2022-05, Vol.41 (3), p.171-181
Hauptverfasser:	Prior, Helen, Clarke, David O, Jones, David, Salicru, Eleni, Schutten, Melissa M, Sewell, Fiona
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Drug Development Humans Symposia Review United States
Online-Zugang:	Volltext
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