Author:
van Hasselt J. G. Coen,Schellens Jan H. M.,Beijnen Jos H.,Huitema Alwin D. R.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Oncology
Reference35 articles.
1. U.S. Food and Drug Administration (2010) Guidance for industry pharmacokinetics in patients with impaired renal function study design, data analysis, and impact on dosing and labeling. Analysis. http://www.fda.gov/downloads/Drugs/Guidances/UCM204959.pdf .
2. Ibrahim S, Honig P, Huang SM et al (2000) Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives. J Clin Pharmacol 40:31–38
3. Zhang Y, Zhang L, Abraham S et al (2009) Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther 85:305–311
4. Committee for medicinal products for human use, European Medicines Agency (2004) Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003123.pdf .
5. Kubitza D, Becka M, Mueck W et al (2010) Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol 70:703–712
Cited by
5 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献