Archive for February, 2021

Balance design and its requirement in the successful establishment of an Anti-Drug Antibody (ADA) cut point is a hot button topic currently. Although it is stated directly in the FDA 2019 guidance that “balance study designs should be used for cut-point determination”, this requirement is not strictly followed within the industry. Many reasons are reported for this lack of adherence to this recommendation the most prevalent one being that this approach is more of a “nice to have” rather than a “must have” for appropriate setting of a cut point during validation. The goal for this e-Chalk Talk is to walk through a general overview of what a balance design is and why it is truly needed to successfully set a cut point for ADA determination.

Join us via Facebook Live for a virtual ribbon cutting to celebrate with Ariadne Software, LLC on February 25 at 4:00pm!