Relative Bioavailability Risk Assessment: A Systematic Approach to Assessing In Vivo Risk Associated With CM&C-Related Changes

• Published in: Journal of pharmaceutical sciences Vol. 108; no. 1; pp. 8 - 17
• Main Authors: Aburub, Aktham, Sperry, David C., Bhattachar, Shobha, Lobo, Evelyn, Ding, Xuan, Rose, John P.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2019
• Subjects: absorption; bioavailability; Biological Availability; Biopharmaceutics - methods; Biopharmaceutics Classification System (BCS); Chemistry, Pharmaceutical - methods; dissolution; Humans; in silico modeling; in vitro model(s); Pharmaceutical Preparations - metabolism; Risk Assessment - methods; Risk Factors; in vitro model(s); in silico modeling; absorption; bioavailability; Biopharmaceutics Classification System (BCS); dissolution

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 (RA) tool that comprehensively and objectively assesses the risk of noncomparable in vivo performance as...