Defining Therapeutic Window for Viral Vectors: A Statistical Framework to Improve Consistency in Assigning Product Dose Values
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.
