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Sticking Assessment Tool
The ETC is seeking companies interested in developing a an empirical method/tool to quantifiably detect and assess the propensity of sticking for a given powder during the early stages of drug development with minimal material and one that is practical in complexity and accessibility. Currently, none of the empirical methods used in literature have been developed to predict sticking.
Over the past decade, several methods to assess sticking were employed by various research groups. In general, these methods can be categorized as either directly or indirectly measuring sticking. Methods that directly attempt to measure sticking, do so by making measurements directly on the material stuck to the punch tip. Indirect methods are correlative and attempt to estimate or predict the severity of sticking based on measurements of other paraments that are related to sticking. To date, there has not been an indirect method that demonstrates the ability to estimate or predict sticking with high reliability. This lack of reliability with indirect methods is largely due to the multi-faceted complexity of the phenomenon of sticking as alluded to earlier.
RFI ISSUED: October 20, 2022
QUESTIONS on RFI DUE to ETC: November 7, 2022
RFI RESPONSES DUE to ETC: December 15 , 2022
EXTENSION for RFI RESPONSES DUE to ETC: June 2, 2023
Q&A - Note see FAQ document for answers to common questions
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