2022
DOI: 10.1016/j.jval.2021.11.100
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POSA27 Are Digital Endpoints Being Used To Support Labelling Claims? A Status Check

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“…Despite increased interest, only a small number of drugs have been approved where DHT data have been used to support labeling claims 2 . To the best of our knowledge, limited information is available about DHT‐driven Go/No Go decisions for drug candidates 3,4 …”
Section: Introductionmentioning
confidence: 99%
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“…Despite increased interest, only a small number of drugs have been approved where DHT data have been used to support labeling claims 2 . To the best of our knowledge, limited information is available about DHT‐driven Go/No Go decisions for drug candidates 3,4 …”
Section: Introductionmentioning
confidence: 99%
“…2 To the best of our knowledge, limited information is available about DHT-driven Go/No Go decisions for drug candidates. 3,4 When considering using data derived from a DHT in a drug development program, study sponsors need to determine what data would be required to support a specific hypothesis. Part of this decision-making process includes the determination of what needs to be measured and how.…”
Section: Introductionmentioning
confidence: 99%
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