@James Polli posted in the Bioequivalence and Bioavailability Science Community:
If you are interested in drug product formulation similarity, we'd appreciate your input, via the "Survey About Best Practices To Facilitate "QQ" Formulation Assessment Of Complex Generics."
The Center for Research in Complex Generics (CRCG) will co-host a workshop on "Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned" in late 2022 that clarifies how FDA conducts test formulation assessments. This survey is intended to help identify topic areas that should be the focus of this workshop.
Your input would be much appreciated, particularly if you have an interest in "QQ". Q1 denotes test and reference products containing the same inactive ingredient (i.e., qualitatively the same). Q2 denotes test and reference products containing the same amounts of inactive ingredients (i.e., quantitatively the same). QQ is used informally to denote both Q1 and Q2.
If you are willing to take a 10-minute survey by June 15, please visit:
complexgenerics.org/qq-survey
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Allison Radwick Ph.D.
Associate Medical Director
Symbiotix
Exton PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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