CRS/AAPS Joint Workshop at the AAPS Annual Meeting

Be sure to join the CRS members Diane Burgess, Mai Huynh, Marilyn Martinez, and Mike Rathbone November 15–16, 2008, at the Critical Variables in the In Vitro and In Vivo Performance of Parenteral Sustained Release Products Workshop. The workshop will be held in conjunction with the 2008 AAPS Annual Meeting in Atlanta, Georgia, and will offer a full two days of expert speakers discussing the topics you want to hear more about. CRS members receive the AAPS member discounted rate when registering for the workshop, so take advantage of this CRS member benefit and register today!

Complex parenteral formulations present an increasingly important mechanism for the delivery of small and large molecules. Because these products generally contained large amounts of drug (to allow for sustained release over days, weeks or months), it is essential that we understand the critical manufacturing and formulation variables influencing product performance. However, development of manufacturing specifications (and the use of design space concepts) is far more difficult that what is generally encountered with oral dosage forms. Furthermore, unlike immediate release dosage forms where traditional methods of setting expiry can assure safe and effective in vivo product performance, it is unclear as to how such test methods need to be modified for products that are intended to release drug for duration of weeks or months after injection. Through the continuation of discussions begun in 2007 (presentations and breakout sessions), it is our hope that we can further refine our understanding of the critical variables influencing the performance of parenteral sustained release products.

The workshop chairs are pleased to bring CRS and AAPS together to offer this outstanding two-day workshop. To whet your appetite, below are a few of the speakers you’ll hear and the topics to be discussed:

Application of Design Space Concepts to Parenteral Products – Kristen Anderson and Greg Hunter, FDA/CVM, U.S.A.

Host Response to Biomaterials and Challenges in In Vitro Release Testing for Parenteral Products – Diane Burgess, University of Connecticut, U.S.A.

Explant Approaches for Estimating In Vivo Drug Release – John Dooley, Cordis Corporation, U.S.A.

Implants – Sanjay Goskonda and Huey-Ching Su, DURECT Corporation, U.S.A.

Developing Performance Specifications and Design Space – Stephen Hoag, University of Maryland, U.S.A.

Stability and Expiry Dating – Mai Huynh, FDA/CVM, U.S.A.

Describing Design Space Concept – Mansoor Khan, FDA/CDER, U.S.A.

Microspheres – Rajesh Kumar, Aklermes, Inc., U.S.A.

Use of Animal Models in Defining In Vitro Specifications – Marilyn Martinez, FDA/CVM, U.S.A.

In Situ Forming Gels, LA Parenteral Suspensions – Franklin Okumu, DURECT Corporation, U.S.A.

Registration is open. Visit www.aapspharmaceutica.com/crs to sign up now.