Workshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
The 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.
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Agenda - Workshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (PDF/112.5 KB)
Draft
First published: 28/10/2015
Last updated: 10/11/2015
EMA/400205/2015 -
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Presentation - Aims of the workshop (Mair Powell) (PDF/121.26 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Non-clinical models to identify PK/PD indices and PD targets In Vitro (George Drusano) (PDF/3.46 MB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Animal infection models: identifying the pharmacologic determinants of efficacy (Sujata M. Bhavnani) (PDF/998.78 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Non-clinical models to identify PK-PD indices and PD targets: industry perspective (Kevin Krause) (PDF/246.62 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - PK data for supporting PK-PD analyses: essential PK data (Elisabet Nielsen, Lena Friberg) (PDF/4.85 MB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - ELF data: study designs, interpretation, role in dose selection (William Hope) (PDF/891.7 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - PK data for supporting PK-PD analyses (David Tenero) (PDF/256.32 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - PK-PD target selection: it’s all about the goal (Paul Ambrose) (PDF/789.84 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - PD targets for various infection types: Stasis vs. 1-Log Kill vs. 2 Log Kill (George Drusano) (PDF/889.99 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - PD targets in non-clinical models: how much bacterial killing? (Michael Dudley) (PDF/492.09 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Estimating the probability of target attainment (George Drusano) (PDF/892.39 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Estimating probability of target attainment (Johan Mouton) (PDF/842.17 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Determination of the probability of target attainment (Matthew Rizk) (PDF/343.96 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Systematic review of clinical PK-PD studies of antibacterials (Alasdair MacGowan) (PDF/369.66 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Exposure - response (Johan Mouton) (PDF/689.06 KB)
First published: 16/03/2016
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Presentation - Clinical exposure - response relationships (Evelyn Ellis-Grosse) (PDF/269.69 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - β-Lactamase inhibitors properties, microbiology and enzymology (David Livermore) (PDF/338.5 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - β-Lactamase inhibitors: the pharmacological basis of therapeutics (Paul Ambrose) (PDF/1.78 MB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Beta-lactamase inhibitors (Shampa Das) (PDF/257.21 KB)
First published: 16/03/2016
Last updated: 16/03/2016 -
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Presentation - Replacing and interpreting clinical data (John Rex) (PDF/429.98 KB)
First published: 16/03/2016
Last updated: 16/03/2016