Special Populations: Influence of Hepatic Impairment

Author:

Sanderink Gerard,Kovar Andreas

Publisher

Springer International Publishing

Reference8 articles.

1. Bruno R, Hille D, Riva A, Vivier N, Ten Bokkel-Huinink WW, Van-Oosterom AT, Kaye SB, Verweij J, Fossella FV, Valero V, Rigas JR, Seidman AD (1998) Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol 16:187–196

2. EMA CPMP/EWP/2339/02 (2005) Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-impaired-hepatic-function_en.pdf

3. FDA (USA) (2003) Guidance for industry: pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling. May 2003, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-hepatic-function-study-design-data-analysis-and-impact-dosing-and 

4. Frye RF, Zgheib NK, Matzke GR, Chaves-Gnecco D, Rabinovitz M, Shaikh OS, Branch RA (2006) Liver disease selectively modulates cytochrome P450-mediated metabolism. Clin Pharmacol Ther 80:235–245

5. Lasseter KC, Dilzer SC, Vargas R, Waldman S, Noveck RJ (2004) Pharmacokinetics and safety of ebastine in patients with impaired hepatic function compared with healthy volunteers: a phase I open-label study. Clin Pharmacokinet 43(2):121–129

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