Relative Bioavailability Risk Assessment: A Systematic Approach to Assessing In Vivo Risk Associated with CM&C related Changes

Abstract Relative bioavailability (RBA) studies are often carried out to bridge changes made between drug products used for clinical studies. In this work we describe the development of a risk assessment tool that comprehensively and objectively assesses the risk of non-comparable in vivo performance associated with CMC lower tier risk, indeterminate tier risk, and upper tier risk. In cases where the outcome from the risk assessment falls into the indeterminate tier risk zone, further in depth data analysis is required.