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Successful Drug Development Despite Adverse Preclinical Findings Part 2: Examples

To illustrate the process of addressing adverse preclinical findings (APFs) as outlined in the first part of this review, a number of cases with unexpected APF in toxicity studies with drug candidates is discussed in this second part. The emphasis is on risk characterization, especially regarding th...

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Detalles Bibliográficos
Autores principales: Ettlin, Robert A., Kuroda, Junji, Plassmann, Stephanie, Hayashi, Makoto, Prentice, David E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Japanese Society of Toxicologic Pathology 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234630/
https://www.ncbi.nlm.nih.gov/pubmed/22272032
http://dx.doi.org/10.1293/tox.23.213