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Record Nr. |
UNINA9910698720203321 |
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Titolo |
Guidance for FDA reviews and sponsors [[electronic resource] ] : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs) |
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Pubbl/distr/stampa |
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Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2008] |
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Descrizione fisica |
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1 online resource (ii, 34 pages) |
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Soggetti |
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Gene therapy |
Drug approval - United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Title from title screen (viewed on Apr. 24, 2009). |
"April 2008". |
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Nota di bibliografia |
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Includes bibliographical references (pages 32-34). |
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