Mark your calendars for the Midwest local event of the International Society of Pharmacometrics on Tuesday, Oct 29

From: ISoP Announcements Date: October 08, 2013 event Source: mail-archive.com
Rational pediatric dose prediction: A role of physiologically-based pharmacokinetic (PBPK) models Andrea N. Edginton PhD, Assistant Professor, School of Pharmacy, University of Waterloo To register for this event, click HERE: https://www.eventbrite.com/event/8693399191 Costs: The registration fee covers refreshments. - $10 for ISoP members and $15 for non-members - Please register by October 28 end of business ISoP members receive a discount! Not yet a member? https://www.regonline.com/Register/Checkin.aspx?EventID=1137693 Click here to become an ISoP member before you register for this event. Abstract: Due to regulatory intervention, pediatric clinical trials are increasing in number. First-in-children study protocols must include the dose(s) that will be used across the included age range. Determining an appropriate dose becomes more difficult to do as age declines. This is because the physiological and biochemical processes that are responsible for drug exposure begin to deviate from that in adults; a sub-population that is generally well studied and reasonably understood. This talk will highlight how PBPK models integrate maturation and growth to derive pediatric doses. It will also highlight the regulatory atmosphere around the use of PBPK models for trial design. Questions? Email us at [email protected]