Simulation-Based Evaluation of PK/PD Indices for Meropenem Across Patient Groups and Experimental Designs

Author:

Kristoffersson Anders N.ORCID,David-Pierson Pascale,Parrott Neil J.,Kuhlmann Olaf,Lave Thierry,Friberg Lena E.,Nielsen Elisabet I.

Funder

F. Hoffman-La Roche

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Reference34 articles.

1. European Medicines Agency. CHMP/EWP/2655/99 - Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003420.pdf . Accessed 29 Jan 2015.

2. European Medicines Agency. Concept Paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162135.pdf . Accessed 29 Jan 2015.

3. U.S. Food and Drug Administration. Developing antimicrobial drugs — General considerations for clinical trials (Draft Guidance). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064980.htm . Accessed 20 Jan 2015.

4. Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis: Off Publ Infect Dis Soc Am. 1998;26:1–10.

5. Gloede J, Scheerans C, Derendorf H, Kloft C. In vitro pharmacodynamic models to determine the effect of antibacterial drugs. J Antimicrob Chemother. 2010;65:186–201.

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