Co-sponsored with 
Complex parenteral formulations present an increasingly important mechanism for the delivery of small and large molecules. Because these products generally contained large amounts of drugs (to allow for sustained release over days, week, or months), it is essential that we understand the critical manufacturing and formulation variables influencing product performance. The development of manufacturing specifications (and the use of design space concepts) is far more difficult than 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 much test methods need to be modified for products that are intended to release drugs for a duration of weeks or months after injection. It is our hope this workshop will refine the understand of the critical variables influencing the performance of parenteral sustained release products.
Flyer
Speakers to include:
Diane Burgess, University of Connecticut, U.S.A.
Susan Cady, Intervet/Schering-Plough Animal Health
Mai Huynh, Food and Drug Administration, U.S.A.
Marilyn Martinez, Food and Drug Administration, U.S.A.
Michael Rathbone, InterAg, New Zealand
Topics to include:
Applications of Design Space Concepts to Parenteral Products
Challenges in Developing In Vitro Tests for Predicting Targeted Drug Delivery
Challenges in In Vitro Release Testing for Parenteral Products
Critical Variables for Setting Biorelevant Specifications for Batch Release and Expiry Dating
Describing Design Space Concept
Explant Approaches for Estimating In Vivo Drug Release
Global Overview
Host Response to Biomaterials
How to Establish the In Vivo Bioequivalence of Long Acting Parenteral Products
Implants
In Situ Forming Gels, Long Acting Parenteral Suspensions
In Vivo Factors that Will Influence Product Specifications
Liposomes and Microspheres
Long Acting Parenteral Solutions
Overview of the Issues
Stability and Expiry Dating
Use of Animal Models in Defining In Vitro Specifications |
