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- W2894539658 abstract "Abstract The time required to develop a new drug takes over 12 years and often much longer, and its development is very expensive. This dilemma was the main reason for launching translational medicine as a potential remedy. From the beginning, it was clear that a pivotal early step in clinical development is the proof-of-concept (PoC) study, typically obtained in the phase IIb clinical trial. It is only a natural consequence to adapt the development strategy for a new drug to obtain a positive PoC as early as possible. This goal was one of the major objectives of the Critical Path Initiative in the United States and similar constructs elsewhere. In this chapter, methods and pathways to accelerate PoC are discussed and examples given." @default.
- W2894539658 created "2018-10-05" @default.
- W2894539658 creator A5045146149 @default.
- W2894539658 date "2015-01-01" @default.
- W2894539658 modified "2023-09-26" @default.
- W2894539658 title "Accelerating Proof-of-Concept by Smart Early Clinical Trials" @default.
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- W2894539658 doi "https://doi.org/10.1016/b978-0-12-800687-0.00027-x" @default.
- W2894539658 hasPublicationYear "2015" @default.
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