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- W2488006064 abstract "Drugs have to demonstrate efficacy and safety and both need to be integrated into a risk–benefit analysis. As there is no precise way to calculate a risk–benefit profile, drug development and approval remain an art rather than a science. Beyond the strength of data, many other factors have to be taken into account. These include current medical needs, variable regulatory contexts, changing legislative and societal environments, tougher operational challenges and higher costs of investment before any potential return. As was the case in the 1990s with AIDS, targeted treatment for oncology and for orphan diseases are now leading the path to innovations and approvals. Breaking old dogmas, new study designs are attempted. Regulations, such as orphan drug designations, breakthrough therapy, or approval under exceptional circumstances stimulate investment and bring flexibility to the approval process. Because of these, the recent trend indicating a decrease in drug approvals is being corrected." @default.
- W2488006064 created "2016-08-23" @default.
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- W2488006064 date "2015-01-01" @default.
- W2488006064 modified "2023-09-25" @default.
- W2488006064 title "What Are Current Main Obstacles to Reach Drug Approval?" @default.
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- W2488006064 doi "https://doi.org/10.1016/b978-0-12-420246-7.00002-5" @default.
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