AAPS-BADG is proud to host our next event
March 9th, 2015 (Thursday), 6:00 - 9:00 pm
Crowne Plaza Foster City, 1221 Chess Drive, Foster City, CA 94404
"Systems based Pharmaceutics: Leveraging Mechanistic Process Modeling Tools to Meet Regulatory Requirements"
Speaker: Dan Briado
Senior Technical Consultant, Process Systems Enterprise Ltd. Regulatory bodies have identified mechanistic modeling as an enabling technology to aid in facilitating more efficient and cost effective delivery of new drug therapies and have also used such models to evaluate systems submitted to them. One of the key benefits of mechanistic models is being able to use limited experimental data to predict performance across a range of values for essentially no additional cost. In addition, it is important to understand the limitations of the models and where additional experimental data or scientific understanding will result in the most impact and improvement to the accuracy or integrity of the model. A Global System Analysis allows for exploration of the theoretical design space as well as highlighting the uncertainty associated with models and the knowledge used to build them. In this talk we will explore some of these models and how they have been applied to pharmaceutical research as well as how the modelling ideology can be incorporated into the pharmaceutical R&D workflow.
"Developing Palatable Drug Products: It's More than Yuck and Yum"
Speaker: David A. Tisi
Technical Director, Senopsys LLC. Regulations in the United States and European Union are stimulating research into the development of drug products specifically labeled for pediatric dosing. The development of palatable oral formulations is important to dosing compliance, particularly for children. Many active pharmaceutical ingredients (APIs) are known to be bitter or have other undesirable sensory attributes including smell or trigeminal irritation. In addition, excipients used to increase drug solubility or for preservation, for example, are known to create or exacerbate the taste masking challenge. This presentation will provide an overview of the tools that are available to enable the development of palatable drug products, whether for children, adults or special needs
6:00pm – 7:00pm Onsite Registration and Networking
7:00pm – 7:45pm Systems based Pharmaceutics: Leveraging Mechanistic Process Modeling Tools to Meet Regulatory Requirements
7:45pm – 8:00pm Q&A
8:00pm – 8:45pm Developing Palatable Drug Products: It's More than Yuck and Yum
8:45pm – 9:00pm Q&A