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...

Descripción completa

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

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152593/
https://www.ncbi.nlm.nih.gov/pubmed/35435047
http://dx.doi.org/10.1177/10915818221081439

Ejemplares similares