Abstract：
:The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is necessary due to the biological and technical complexity of these products in general. This chapter provides an overview of the US FDA regulatory oversight of gene and cell therapy products.
journal_name
Adv Exp Med Bioljournal_title
Advances in experimental medicine and biologyauthors
Bailey AM,Arcidiacono J,Benton KA,Taraporewala Z,Winitsky Sdoi
10.1007/978-3-319-18618-4_1subject
Has Abstractpub_date
2015-01-01 00:00:00pages
1-29eissn
0065-2598issn
2214-8019journal_volume
871pub_type
杂志文章,评审abstract：:Lung cancer is the leading cause of cancer-related deaths world-wide and small-cell lung cancer (SCLC) accounts for up to 25% of lung cancer deaths. There has been a considerable amount of research in the understanding of the depth of biology of SCLC and utilizing this knowledge to develop targeted approaches. The tre...
journal_title：Advances in experimental medicine and biology
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pub_type： 杂志文章
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abstract：:Taurine is traditionally used to treat Down Syndrome (DS); however, the actual foundation for this treatment is not well understood. DS patients suffer from disturbance of the proteostasis network (PN) due to aberrant calcium signaling, which eventually causes endoplasmic reticulum stress (ERS). Taurine has been sugge...
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journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-1-4615-9038-5_26
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journal_title：Advances in experimental medicine and biology
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更新日期：2012-01-01 00:00:00
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pub_type： 杂志文章
doi：10.1007/978-3-030-32633-3_30
更新日期：2020-01-01 00:00:00
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更新日期：2003-01-01 00:00:00
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doi：10.1007/978-1-4899-1016-5_24
更新日期：1995-01-01 00:00:00
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doi：10.1007/978-3-319-39824-2_3
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journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4615-7703-4_16
更新日期：1991-01-01 00:00:00
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abstract：:Voltage- and ligand-gated ion channels are key elements in the etiopathogenesis of various forms of epilepsy. In this chapter, we present an overview of the functional implications of voltage-gated Ca(2+) channels in modulating internal Ca(2+) level fluctuations and generating ictiform/epileptiform cellular electrophy...
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更新日期：1995-01-01 00:00:00
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pub_type： 杂志文章
doi：10.1007/978-1-4615-2872-2_62
更新日期：1993-01-01 00:00:00
abstract：:Intracellular changes in immune cells lead to metabolic dysfunction, which is termed immunometabolism. Chronic inflammation is a hallmark of aging; this phenomenon is described as inflamm-aging. Immunometabolism and inflamm-aging are closely linked to obesity, insulin resistance, type 2 diabetes (T2D), cardiovascular ...
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pub_type： 杂志文章,评审
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pub_type： 杂志文章
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更新日期：2013-01-01 00:00:00
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journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：
更新日期：1979-01-01 00:00:00
abstract：:Measurements demonstrating low-frequency underwater sound attenuation using arrays of large, tethered, stationary encapsulated bubbles to surround a sound source were compared with various effective medium models for the acoustic dispersion relationship in bubbly liquids. Good agreement was observed between measuremen...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4939-2981-8_73
更新日期：2016-01-01 00:00:00
