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1.
EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells.
Br J Clin Pharmacol
; 90(5): 1203-1212, 2024 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-38565322
2.
[Combination therapies in immuno-oncology: differentiated regulatory approaches]. / Kombinationstherapien in der Immunonkologie: Differenzierte regulatorische Herangehensweisen.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
; 63(11): 1388-1395, 2020 Nov.
Artículo
en Alemán
| MEDLINE | ID: mdl-33084926
3.
Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach.
Cancer Immunol Immunother
; 67(4): 513-523, 2018 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-29380009
4.
Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.
Transfus Med Hemother
; 42(3): 194-9, 2015 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-26195933
5.
[Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products]. / Wissenschaftliche Beratung durch nationale und europäische Zulassungsbehörden bei Arzneimitteln für neuartige Therapien.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
; 58(11-12): 1207-14, 2015 Nov.
Artículo
en Alemán
| MEDLINE | ID: mdl-26369763
6.
Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 160: 112-133, 2022 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34840026
7.
The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?
Trends Biotechnol
; 37(2): 120-123, 2019 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-30017092
8.
Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts.
EMBO Mol Med
; 9(9): 1183-1197, 2017 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-28765140
9.
Cell-based therapies for cardiac repair: a meeting report on scientific observations and European regulatory viewpoints.
Eur J Heart Fail
; 18(2): 133-41, 2016 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-26470631
10.
Regulatory watch: European regulatory experience with advanced therapy medicinal products.
Nat Rev Drug Discov
; 18(1): 8-9, 2019 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30498203
11.
Challenges with advanced therapy medicinal products and how to meet them.
Nat Rev Drug Discov
; 9(3): 195-201, 2010 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-20190786
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