The IVRDT Community Instrumentation Subgroup will give a Rapid Fire Speak at the 2023 PharmSci 360 with the title
Non-Compendial Small Volume Dissolution for Early-Stage Formulation Model Development
Date: Wednesday October 25, 2023
Time: 3:00 PM-3:15 PM
As they become more varied and complex, new formulations optimization in early-stage development increasingly relies on modeling and other indirect techniques. In support of these, the need for actual reference data becomes an even more pressing challenge. With limited amounts of material available, tests such as dissolution at standard compendial volumes remain impractical. Fortunately, an array of non-compendial small volume dissolution testing solutions have become commercially available, and their popularity (along with a desire to harmonize with the Chinese Pharmacopeia, which explicitly defines such a setup) has led to the USP launching a program to begin reviewing some of these solutions for possible inclusion in the General Chapters. This Rapid Fire talk will summarize these needs, currently available solutions, and some questions for standardization, and paths one can utilize today that will probably remain valid approaches after the introduction of regulations.
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Steve Prufer
Head of Application
ERWEKA GmbH
Langen
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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