Clinical Pharmacology – Biomolecular
This presentation will examine the design and analysis of trials used to determine biosimilarity from a statistical/quantitative perspective. There are numerous challenges faced by those conducting such trials. Currently there is no guidance on which quantitative standards should be used. This presentation will discuss some of the challenges of conducting the trials (from a statistical/quantitative perspective), review methods that are currently utilized for such trials, and discuss some alternative approaches for the design and analysis of the trials.