Uncertainty Quantification In Pharmaceutical Development

Every pharmaceutical product that is approved and released to the public is shaped by countless decisions made at the research and clinical stages of development. The efficacy and safety of these products depends on the quality of these decisions. In this paper we examine how modern probability tools might be used to raise the quality of such decisions. Specifically we are arguing for the greater use of Bayesian probability tools in pharmaceutical product development decision making. A case study on a novel Bayesian treatment of shelf life determination for lyophilized parenteral is presented.