Using Population Pharmacokinetics to Support the Development of Clinically Relevant Specifications for Extended Formulations

A workshop co-sponsored by the American Association of Pharmaceutical Scientists and the Controlled Release Society

Saturday, November 13, 2010

Morial Convention Center, New Orleans, Louisiana, U.S.A.
To be held immediately prior to the FIP Pharmaceutical Sciences World Congress 2010 in association with the AAPS Annual Meeting - http://www.pswc2010.org/

The Quality by Design (QbD) paradigm is ushering in new approaches for achieving a streamlined, knowledge-based process for generating products optimized to meet patient needs. Development of a Quality Target Product Profile (QTPP) can help maximize the likelihood of achieving the therapeutic objective by linking critical product quality attributes (CQAs) to the desired in vivo performance. In this workshop, we will discuss developing a QTPP through PK/PD modeling and simulation approaches that will enable linking CQAs to clinical outcome. Through the integration of population PK/PD models established on the basis of clinical trial data, this integrative approach could ensure the establishment of in vitro drug dissolution/release methods that link to the desired in vivo product performance, thereby providing dissolution/release criteria that are consistently informative and clinically relevant.

WHO SHOULD ATTEND: bench and clinical scientists involved in the development or regulation of modified release formulations and the optimization of dosing strategies.

REGISTRATION

Preregistration ends November 3, 2010. After that date, you must register onsite in New Orleans.

Regular
On or before September 10 - $995

Late/Onsite
After September 11 or onsite - $1095

3 Easy Ways to Register

Online: www.pswc2010.org
Mail or Fax: Visit www.pswc2010.org to download the registration form

Mail to:
2010 FIP PSWC/AAPS Annual Meeting & Exposition
PO Box 590
Frederick, MD 21705 U.S.A.

Meeting Registration/Questions
Phone: +1.301.694.5234
Toll-Free (U.S.A., Canada, Mexico): 1.866.229.2386

ACCOMMODATIONS

The Hilton New Orleans Riverside will serve as the headquarters hotel for this meeting. Rooms have also been reserved at several New Orleans hotels. You must reserve your room by October 22, 2010, to guarantee the meeting rate. Call the PSWC Housing Bureau at 1.800.724.0858 or visit www.pswc2010.org to make your reservation.