This open access article was co-authored with my statistical consultant colleague of 30+ years. In it we propose using an equivalence approach for lot release testing of vector products. Because dose related toxicity is a concern, dose assays must be accurate and precise enough to yield a reliable estimate. We provided a worked through example to convey the key concepts.
https://sajjadiconsulting.com/wp-content/uploads/2020/01/publicationsblog.jpg 1440 1920 firstname.lastname@example.org https://sajjadiconsulting.com/wp-content/uploads/2021/08/sajjadi-logo-web.png email@example.com 15:18:312021-09-28 09:21:30Defining Therapeutic Window for Viral Vectors: A Statistical Framework to Improve Consistency in Assigning Product Dose Values