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- W2495289907 abstract "The sequencing of the human genome and the emergence of other omics-based technologies have provided drug discoverers with powerful new tools that can be used as a framework for understanding disease mechanisms and predicting patient outcomes. This chapter identifies specific questions that may arise when evaluating the potential regulatory impact of a new technology. It also spots the type of criteria that can be used to determine whether a new tool has general applicability as a basis for regulatory decision-making in drug development. In designing a safety pharmacology program to support a new regulatory submission, the ICH S7A Tripartite Guideline encourages the use of new technologies and methodologies. As scientific advances continue to yield with new tools and technologies with better performance characteristics and predictive power than the traditional assays and biomarkers used in drug development, it will find their way into regulatory decision-making." @default.
- W2495289907 created "2016-08-23" @default.
- W2495289907 creator A5070362977 @default.
- W2495289907 date "2016-03-24" @default.
- W2495289907 modified "2023-09-23" @default.
- W2495289907 title "Emerging Technologies and their Role in Regulatory Review" @default.
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- W2495289907 doi "https://doi.org/10.1002/9781119053248.ch1" @default.
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