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

• Date:
  Thursday, 12 November 2015
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

DraftReference Number: EMA/400205/2015

Presentation - Aims of the workshop (Mair Powell)

Presentation - Non-clinical models to identify PK/PD indices and PD targets In Vitro (George Drusano)

Presentation - Animal infection models: identifying the pharmacologic determinants of efficacy (Sujata M. Bhavnani)

Presentation - Non-clinical models to identify PK-PD indices and PD targets: industry perspective (Kevin Krause)

Presentation - PK data for supporting PK-PD analyses: essential PK data (Elisabet Nielsen, Lena Friberg)

Presentation - ELF data: study designs, interpretation, role in dose selection (William Hope)

Presentation - PK data for supporting PK-PD analyses (David Tenero)

Presentation - PK-PD target selection: it’s all about the goal (Paul Ambrose)

Presentation - PD targets for various infection types: Stasis vs. 1-Log Kill vs. 2 Log Kill (George Drusano)

Presentation - PD targets in non-clinical models: how much bacterial killing? (Michael Dudley)

Presentation - Estimating the probability of target attainment (George Drusano)

Presentation - Estimating probability of target attainment (Johan Mouton)

Presentation - Determination of the probability of target attainment (Matthew Rizk)

Presentation - Systematic review of clinical PK-PD studies of antibacterials (Alasdair MacGowan)

Presentation - Exposure - response (Johan Mouton)

Presentation - Clinical exposure - response relationships (Evelyn Ellis-Grosse)

Presentation - β-Lactamase inhibitors properties, microbiology and enzymology (David Livermore)

Presentation - β-Lactamase inhibitors: the pharmacological basis of therapeutics (Paul Ambrose)

Presentation - Beta-lactamase inhibitors (Shampa Das)

Presentation - Replacing and interpreting clinical data (John Rex)