Workshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products

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TitleWorkshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
Date12/11/2015 - 13/11/2015
LocationEuropean Medicines Agency, London, UK
SummaryThe objective of the workshop is to discuss the important advances made in the field of pharmacokinetics-pharmacodynamics of antibacterial agents since the entry into force of the Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99). The workshop take place during the six-months consultation period for the new draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (EMA/CHMP/594085/2015). It is expected that the discussions will contribute to shaping the final draft guideline. The workshop is one of the key activities of the European Medicines Agency (EMA) to facilitate development of new antibiotics (including those targeting the treatment of multi-resistance bacteria) and is part of EMA's contribution to the global efforts of tackling antimicrobial resistance. Registration by invitation only.

All documents

Name Language First published Last updated
Agenda - Workshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (English only) 2015-10-28 2015-11-10
Presentation - Aims of the workshop (Mair Powell) (English only) 2016-03-16  
Presentation - Non-clinical models to identify PK/PD indices and PD targets In Vitro (George Drusano) (English only) 2016-03-16  
Presentation - Animal infection models: identifying the pharmacologic determinants of efficacy (Sujata M. Bhavnani) (English only) 2016-03-16  
Presentation - Non-clinical models to identify PK-PD indices and PD targets: industry perspective (Kevin Krause) (English only) 2016-03-16  
Presentation - PK data for supporting PK-PD analyses: essential PK data (Elisabet Nielsen, Lena Friberg) (English only) 2016-03-16  
Presentation - ELF data: study designs, interpretation, role in dose selection (William Hope) (English only) 2016-03-16  
Presentation - PK data for supporting PK-PD analyses (David Tenero) (English only) 2016-03-16  
Presentation - PK-PD target selection: it’s all about the goal (Paul Ambrose) (English only) 2016-03-16  
Presentation - PD targets for various infection types: Stasis vs. 1-Log Kill vs. 2 Log Kill (George Drusano) (English only) 2016-03-16  
Presentation - PD targets in non-clinical models: how much bacterial killing? (Michael Dudley) (English only) 2016-03-16  
Presentation - Estimating the probability of target attainment (George Drusano) (English only) 2016-03-16  
Presentation - Estimating probability of target attainment (Johan Mouton) (English only) 2016-03-16  
Presentation - Determination of the probability of target attainment (Matthew Rizk) (English only) 2016-03-16  
Presentation - Systematic review of clinical PK-PD studies of antibacterials (Alasdair MacGowan) (English only) 2016-03-16  
Presentation - Exposure - response (Johan Mouton) (English only) 2016-03-16  
Presentation - Clinical exposure - response relationships (Evelyn Ellis-Grosse) (English only) 2016-03-16  
Presentation - β-Lactamase inhibitors properties, microbiology and enzymology (David Livermore) (English only) 2016-03-16  
Presentation - β-Lactamase inhibitors: the pharmacological basis of therapeutics (Paul Ambrose) (English only) 2016-03-16  
Presentation - Beta-lactamase inhibitors (Shampa Das) (English only) 2016-03-16  
Presentation - Replacing and interpreting clinical data (John Rex) (English only) 2016-03-16  

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