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150915s2015 gw | s |||| 0|eng d |
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|a 9783319186184
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024 |
7 |
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|a 10.1007/978-3-319-18618-4
|2 doi
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|a Sistema de Bibliotecas del Tecnológico de Costa Rica
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245 |
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|a Regulatory Aspects of Gene Therapy and Cell Therapy Products :
|b A Global Perspective /
|c edited by Maria Cristina Galli, Mercedes Serabian.
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250 |
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|a 1st ed. 2015.
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260 |
# |
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|a Cham :
|b Springer International Publishing :
|b Imprint: Springer,
|c 2015.
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300 |
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|a XII, 230 p. 23 illus., 17 illus. in color. :
|b online resource.
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336 |
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|a text
|b txt
|2 rdacontent
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|a computer
|b c
|2 rdamedia
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|a online resource
|b cr
|2 rdacarrier
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|a American Society of Gene & Cell Therapy,
|v 871
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|a 1. Regulatory Oversight of Gene Therapy and Cell Therapy Products in the US - FDA/CBER -- 2. US Oversight of Gene Therapy Products – NIH RAC -- 3. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Canada - Health Canada -- 4. Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products -- 5. Regulation of Clinical Trials with Advanced Therapy Medicinal Products (ATMP) in Germany -- 6. EU Clinical Trials Regulatory Oversight of Advanced Therapy Medicinal Products (ATMP): Perspectives from Various Member States -- 7. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Switzerland - Swissmedic -- 8. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Japan - Japan Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Device Agency (PMDA) -- 9. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea - Korean Ministry of Food and Drug Safety (MFDS) -- 10. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Taiwan - Taiwan Food and Drug Administration (TFDA) -- 11. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Singapore - Singapore Health Science Authorities (HSA) -- 12. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Brazil - National Health Surveillance Agency (ANVISA).
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|a Gene therapy.
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650 |
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|a Gene Therapy.
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|a Galli, Maria Cristina.
|e editor.
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|a Serabian, Mercedes.
|e editor.
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710 |
2 |
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|a SpringerLink (Online service)
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773 |
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|t Springer eBooks
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