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- W2485192634 abstract "The drug development process and clinical evaluation of a potential drug for Alzheimer’s disease (AD) is strongly influenced by the guidelines issued by regulatory authorities world-wide.Since the early 1990s these have been primarily those issued by the Food and Drug Administration (FDA) in the United States and by the Committee for Proprietary Medicinal Products (CPMP) in Europe. Such guidelines reflect both regulatory policy and the prevailing consensus of expert scientific and medical opinion. They cover the theoretical and practical issues affecting the validity and reliability of clinical investigations carried out in dementia. The guidelines are not regulations as such, but they do summarize the advice that agency staff give to those seeking direction on how to obtain an antidementia drug claim. It is therefore understandable that drug developers adhere closely to the guidelines and dementia trials to date have had a common format. This is clearly demonstrated by the similarity in the design of the trials supporting the approval of Cognex™ and Aricept™ for AD." @default.
- W2485192634 created "2016-08-23" @default.
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- W2485192634 date "1998-01-01" @default.
- W2485192634 modified "2023-09-23" @default.
- W2485192634 title "How Can we Improve the Drug Development Process in Alzheimer’s Disease?" @default.
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- W2485192634 doi "https://doi.org/10.1007/978-1-4615-5337-3_120" @default.
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