Quantitative Benefit-Risk Assessment: State of the Practice Within Industry.
Meredith Y SmithJanine Astrid van TilRachael L DiSantostefanoA Brett HauberKevin MarshPublished in: Therapeutic innovation & regulatory science (2020)
qBRA application within this sample of life sciences companies was widespread, but concentrated in a small fraction of assets. Its use was primarily for internal decision-making or regulatory submissions. While some companies had plans to build further capacity in this area, others were waiting for further regulatory guidance before doing so.