Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | van den Bos, Christian | - |
dc.contributor.author | Jossen, Valentin | - |
dc.contributor.author | Eibl, Dieter | - |
dc.contributor.author | Eibl-Schindler, Regine | - |
dc.date.accessioned | 2020-03-05T14:59:17Z | - |
dc.date.available | 2020-03-05T14:59:17Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 0031-711X | de_CH |
dc.identifier.issn | 1616-7074 | de_CH |
dc.identifier.uri | https://digitalcollection.zhaw.ch/handle/11475/19663 | - |
dc.description.abstract | We review the GMP/regulatory experience with advanced therapy medicinal products (ATMPs) approximately 10 years after EC regulation 1394/2007, aka the ATMP regulation applied. Particularly, we discuss practical issues which have arisen during this period and which pertain to quantitative aspects of specifications of such products - both allogenic and autologous - and how these perceived hurdles may help in identifying truly useful products. We further review the impact the ATMP-GMP specific guideline might have and how it reflects the experience gathered. Finally, we shed light on combinations of small molecule drugs and ATMPs; we provide an example of the efficacy of such combination products as well as an outlook concerning their classifications. | de_CH |
dc.language.iso | en | de_CH |
dc.publisher | Editio Cantor Verlag | de_CH |
dc.relation.ispartof | Die Pharmazeutische Industrie : pharmind | de_CH |
dc.rights | Licence according to publishing contract | de_CH |
dc.subject.ddc | 615: Pharmakologie und Therapeutik | de_CH |
dc.title | Advanced therapy medicinal products (ATMPs) & GMP : 10 years after | de_CH |
dc.type | Beitrag in Magazin oder Zeitung | de_CH |
dcterms.type | Text | de_CH |
zhaw.departement | Life Sciences und Facility Management | de_CH |
zhaw.organisationalunit | Institut für Chemie und Biotechnologie (ICBT) | de_CH |
zhaw.funding.eu | No | de_CH |
zhaw.issue | 4 | de_CH |
zhaw.originated.zhaw | Yes | de_CH |
zhaw.pages.end | 513 | de_CH |
zhaw.pages.start | 508 | de_CH |
zhaw.publication.status | publishedVersion | de_CH |
zhaw.volume | 81 | de_CH |
zhaw.webfeed | Verfahrenstechnik | de_CH |
zhaw.author.additional | No | de_CH |
Appears in collections: | Publikationen Life Sciences und Facility Management |
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van den Bos, C., Jossen, V., Eibl, D., & Eibl-Schindler, R. (2019). Advanced therapy medicinal products (ATMPs) & GMP : 10 years after. Die Pharmazeutische Industrie : Pharmind, 81(4), 508–513.
van den Bos, C. et al. (2019) ‘Advanced therapy medicinal products (ATMPs) & GMP : 10 years after’, Die Pharmazeutische Industrie : pharmind, 81(4), pp. 508–513.
C. van den Bos, V. Jossen, D. Eibl, and R. Eibl-Schindler, “Advanced therapy medicinal products (ATMPs) & GMP : 10 years after,” Die Pharmazeutische Industrie : pharmind, vol. 81, no. 4, pp. 508–513, 2019.
VAN DEN BOS, Christian, Valentin JOSSEN, Dieter EIBL und Regine EIBL-SCHINDLER, 2019. Advanced therapy medicinal products (ATMPs) & GMP : 10 years after. Die Pharmazeutische Industrie : pharmind. 2019. Bd. 81, Nr. 4, S. 508–513
van den Bos, Christian, Valentin Jossen, Dieter Eibl, and Regine Eibl-Schindler. 2019. “Advanced Therapy Medicinal Products (ATMPs) & GMP : 10 Years After.” Die Pharmazeutische Industrie : Pharmind 81 (4): 508–13.
van den Bos, Christian, et al. “Advanced Therapy Medicinal Products (ATMPs) & GMP : 10 Years After.” Die Pharmazeutische Industrie : Pharmind, vol. 81, no. 4, 2019, pp. 508–13.
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