A survey of renal impairment pharmacokinetic studies for new oncology drug approvals in the USA from 2010 to early 2015: a focus on development strategies and future directions

The US Food and Drug Administration (FDA) issued a guidance document in 2010 on pharmacokinetic (PK) studies in renal impairment (RI) on the basis of observations that substances such as uremic toxins might result in altered drug metabolism and excretion. No specific recommendations for oncology dru...

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Detalles Bibliográficos
Autores principales: Xiao, Jim J., Chen, Jiyun S., Lum, Bert L., Graham, Richard A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2017
Materias:
Review Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515635/
https://www.ncbi.nlm.nih.gov/pubmed/28542036
http://dx.doi.org/10.1097/CAD.0000000000000513

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515635/
https://www.ncbi.nlm.nih.gov/pubmed/28542036
http://dx.doi.org/10.1097/CAD.0000000000000513

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