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Quantitative Benefit-Risk Assessment: State of the Practice Within Industry.

Meredith Y SmithJanine Astrid van TilRachael L DiSantostefanoA Brett HauberKevin Marsh
Published 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.
Keyphrases
  • risk assessment
  • decision making
  • transcription factor
  • primary care
  • human health
  • high resolution
  • heavy metals
  • quality improvement