How to Implement Pharmacokinetics / Pharmacodynamics in Drug Development and Evaluation

an educational workshop held in In cooperation with the  9th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

Scientific organizer: Prof. F. Sörgel, Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.

Pre-meeting Introduction (goals and format)

Slides presented by the some of the speakers at this workshop are available on this site as "Web slide shows".  To view them, click on the title of the lectures.  These slides, which reflect the views of their authors and should not be taken as being endorsed by ISAP, are for information purposes only.  They cannot be reproduced or used for any form of  presentations without the autorization of their author and of ISAP. Please, contact the ISAP Webmaster for further information.

Hans Kohlhoff : 'City Limits'

Welcome by ISAP (Paul M. Tulkens, Brussels, Belgium) Introduction and organization remarks (F. Sörgel, Nürnberg, Germany) The chemical basis of pharmacokinetics and pharmacodynamics of anti-infectives* (F. Sörgel, Nürnberg, Germany) PK/PD in action: Drusano's views (George L. Drusano, Albany Medical College, Albany, NY) Pharmacodynamics: Issues of concern (Ch. Nightingale, Hartford Hospital, Hartford, Conn.) Serum concentrations and  MICs in the development of  PK/PD relationships: advantages and limitations (O. Cars, University Hospital, Uppsala, Sweden) PK/PD in action: animal models (W.A. Craig, University of Wisconsin, Madison, WI) Theoretical concepts and practical examples of PK/PD (J. Mouton, Casinius Whilelmina Hospital, Nijmegen, The Netherlands) Intracellular anti-infectives: is it important for efficacy and do we need to care for toxicity ? (F. Van Bambeke, Brussels, Belgium) PK/PD in action: A view from the patient* (P.M. Tulkens, Brussels, Belgium) * because of time constraints and of vivid, longer than expected discussions, these lectures were skipped.

Pharmacokinetics and Pharmacodynamics (PK/PD) have now become essential tools for determining the appropriate use of currently available anti-infective agents as well as for accelerating the development of new drugs.  While this is now more and more recognized by Academia, Industry and Regulatory Agencies (see the last ISAP/FDA workshop held on March 1st, 1999), there is presently a lack of training into these disciplines.  Accordingly, ISAP has endeavoured to launch educational activities in this context.  The aim is to train people professionally involved in development or in the use of antiinfective drugs in the basic and applied aspects of pharmacokinetics and pharmacodynamics, showing how these sciences have emerged over the last 10 years and how their influence has grown.

The present workshop will be the first of a series to be held annually.

Key ISAP members will review the litterature and will also present important, new concepts.  All presenters will not only acknowledge the participants' wishes to obtain a fundamental understanding of PK/PD but will also give one or more examples taken from their published work.  Educational material will be available for all talks.

The workshop will be informal and each part will consist of a 20 minutes talk followed by a 10 minutes "Questions & Answers" period.  Every participant will be encouraged to ask questions (there are no stupid questions !!).

There will be no break of the morning and afternoon sessions as there will be enough coffee and donuts at the back of the meeting room to maintain appropriate caffeine and glucose levels. The meeting will start mid-morning on Sunday March 21 (to allow one to sleep in on Sunday, arrive on a morning flight, or simply to take an early morning walk to celebrate the coming of Spring) and still  have enough time to participate in the Opening Ceremony of the 9th ECCMID.  The will just be a short lunch break..

Each participant will receive a certificate for participation.