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- W1415679560 abstract "Advances in molecular biology have contributed to a growing interest in gene therapy as a form of treatment for neurological diseases. Implementation, however, requires knowledge of the regulatory policies governing this field of research, especially in view of the greater stringency imposed by the serious adverse events affecting some patients participating in gene therapy protocols. Educational resources accessible to basic and clinical scientists hoping to bring their work to the clinical forefront in the form of a gene therapy protocol for a phase I clinical trial are not available through any single source. The steps involved can be arduous and incredibly time-consuming, including laboring through many documents to discover the route to implementation of a clinical protocol for gene therapy. In this chapter, the authors have summarized the steps involved including: the regulatory agencies and their requirements, the phases of clinical development with emphasis on a phase I study, and specific steps leading to an Investigational New Drug (IND) application for a biological product to be used in a gene therapy clinical trial. Links are provided to all appropriate websites, which will facilitate the efforts for investigators." @default.
- W1415679560 created "2016-06-24" @default.
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- W1415679560 date "2006-01-01" @default.
- W1415679560 modified "2023-10-16" @default.
- W1415679560 title "Gene Transfer for Neurological Disease: Agencies, Policies, and Process**This work was supported in part by funding from National Institutes of Health, National Institute of Arthritis, Musculoskeletal, and Skin Diseases RFA: AR-03-001" @default.
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- W1415679560 doi "https://doi.org/10.1016/b978-012397632-1/50008-3" @default.
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