In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|November 18, 2019
USP General Chapter Open for Public Comment
Author(s)BioPharm International Editors
The chapter is open for comment until Nov. 30, 2019.
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USP General Chapter <1108> Assays to Evaluate Fragment Crystallizable (Fc)-Mediated Effector Function is now open for public comment online in the Pharmacopeial Forum 45(5) until Nov. 30, 2019.
The new general chapter was created to give users guidance regarding the selection, development, and validation of Fc function assays, including the measurement of low-affinity interactions observed with Fc gamma receptors (FcγR) and the impact of glycosylation on antibody effector function.
The Fc region plays a
The chapter can be accessed for free at
Source: USP
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