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The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.
Hum Gene Ther Clin Dev. 2013 Jun;24(2):47-54. doi: 10.1089/humc.2013.119.
Hum Gene Ther Clin Dev. 2013.
PMID: 23862696
Free article.
The advanced therapy classification procedure. Overview of experience gained so far.
Voltz-Girolt C, Celis P, Boucaumont M, D'Apote L, Pinheiro MH, Papaluca-Amati M.
Voltz-Girolt C, et al.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jul;54(7):811-5. doi: 10.1007/s00103-011-1309-y.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011.
PMID: 21698533
Review.
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Regulatory watch: European regulatory experience with advanced therapy medicinal products.
Barkholt L, Voltz-Girolt C, Raine J, Salmonson T, Schüssler-Lenz M.
Barkholt L, et al. Among authors: voltz girolt c.
Nat Rev Drug Discov. 2019 Jan;18(1):8-9. doi: 10.1038/nrd.2018.200. Epub 2018 Nov 30.
Nat Rev Drug Discov. 2019.
PMID: 30498203
No abstract available.
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The Roadmap to Integrate Diversity, Equity, and Inclusion in Hematology Clinical Trials: An American Society of Hematology Initiative.
Kuaban A, Croker A, Keefer J, Valentino LA, Bierer BE, Boateng S, DiMichele DM, Fogarty P, Gibson MC, Hood AM, Hubbard L, Isgrò A, Knobe K, Lake L, Martin I, Reid MM, Roberts JC, Tomlinson W, Tunji-Ajayi L MSM, Van Spall H, Voltz-Girolt CH, Wheeler AP, Mast AE, Seremetis S.
Kuaban A, et al. Among authors: voltz girolt ch.
Blood Adv. 2024 Dec 9:bloodadvances.2024013945. doi: 10.1182/bloodadvances.2024013945. Online ahead of print.
Blood Adv. 2024.
PMID: 39652409
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