hdr isap 2019


EMA - Regulatory guideline and workshop

EMA invited members of the European PK/PD study group and members of ISAP to a workshop discussing pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products. The presentations and discussions will support the drafting of a regulatory guideline for developers on PK/PD of antibacterial agents, as proposed by the concept paper. Comments are welcomed by Oct 23 (email to utheuretzbacher(at)cefaia.com).

In September 2012 the ISAP task force "Individualized Dosing" was initiated, to be led by J. Roberts and J. Kuti, with a goal of supporting physicians in optimizing and individualizing dosing in critically ill patients.

ISAP publication - Bedside dosing!
Lancet Infect Dis April 2014

Individualised antibiotic dosing for patients who are critically ill: challenges and potential solutions

Jason A Roberts, Mohd H Abdul-Aziz, Jeff rey Lipman, Johan W Mouton, Alexander A Vinks, Timothy W Felton, William W Hope, Andras Farkas, Michael N Neely, Jerome J Schentag, George Drusano, Otto R Frey, Ursula Theuretzbacher, Joseph L Kuti, on behalf of The International Society of Anti-Infective Pharmacology and the Pharmacokinetics and Pharmacodynamics Study Group of the European Society of Clinical Microbiology and Infectious Diseases. Lancet Infect Dis. 2014 Jun;14(6):498-509

ISAP and EPASG recently published this review on individualised dosing for critically ill patients. In this review, we explore the challenges related to patients and pathogens that contribute to inadequate antibiotic dosing and discuss how to implement a process for individualised antibiotic therapy that increases the accuracy of dosing and optimises care for critically ill patients.

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