Utilization of phase I studies for target validation of first-in-class drugs Article Swipe
Yoshiki Kawabe
,
Motomu Himori
,
Yoshinori Watanabe
,
Jacob D. Davis
,
Hiromasa Hamada
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1016/j.drudis.2024.104200
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1016/j.drudis.2024.104200
This review discusses the growing importance of target validation within phase I (P1) trials as a new trend in drug development, especially in establishing proof of concept (POC) for first-in-class drugs. The paper describes two approaches: the P1-PIV approach, which directly evaluates the primary endpoint for a pivotal clinical study to confirm therapeutic effects during P1, and the newly introduced P1-FCTE, which assesses functional changes necessary for therapeutic effect as a novel target validation milestone in P1. By providing practical examples of first-in-class drugs, we compare the benefits, costs, hurdles and applicable therapeutic areas of these approaches. Finally, we discuss the potential of these novel approaches to facilitate POC success, shorten development timelines and ultimately increase drug discovery success rates.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.drudis.2024.104200
- OA Status
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- References
- 68
- Related Works
- 10
- OpenAlex ID
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All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4403243428Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1016/j.drudis.2024.104200Digital Object Identifier
- Title
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Utilization of phase I studies for target validation of first-in-class drugsWork title
- Type
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reviewOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
- Publication date
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2024-10-09Full publication date if available
- Authors
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Yoshiki Kawabe, Motomu Himori, Yoshinori Watanabe, Jacob D. Davis, Hiromasa HamadaList of authors in order
- Landing page
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https://doi.org/10.1016/j.drudis.2024.104200Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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hybridOpen access status per OpenAlex
- OA URL
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https://doi.org/10.1016/j.drudis.2024.104200Direct OA link when available
- Concepts
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Milestone, Timeline, Drug development, Class (philosophy), Computer science, Drug class, Drug discovery, Risk analysis (engineering), Clinical trial, Drug, Medicine, Data science, Pharmacology, Bioinformatics, Artificial intelligence, Biology, Mathematics, Pathology, Statistics, History, ArchaeologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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68Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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