169 related articles for article (PubMed ID: 23216470)
1. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).
Jones DR; McBlane JW; McNaughton G; Rajakumaraswamy N; Wydenbach K
Br J Clin Pharmacol; 2013 Aug; 76(2):203-9. PubMed ID: 23216470
[TBL] [Abstract][Full Text] [Related]
2. [Approval of clinical trials with biological medicinal products].
Gross S; Jost N; Hartmann JP
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2017 Aug; 60(8):826-829. PubMed ID: 28677049
[TBL] [Abstract][Full Text] [Related]
3. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?
Boráň T; Menezes-Ferreira M; Reischl I; Celis P; Ferry N; Gänsbacher B; Krafft H; Lipucci di Paola M; Sladowski D; Salmikangas P
Hum Gene Ther Clin Dev; 2017 Sep; 28(3):126-135. PubMed ID: 28510497
[TBL] [Abstract][Full Text] [Related]
4. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe.
Schneider CK; Schäffner-Dallmann G
Nat Rev Drug Discov; 2008 Nov; 7(11):893-9. PubMed ID: 18974748
[TBL] [Abstract][Full Text] [Related]
5. Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics.
Looper YJ
Curr Opin Drug Discov Devel; 2010 Mar; 13(2):247-56. PubMed ID: 20205058
[TBL] [Abstract][Full Text] [Related]
6. [The inspection by the Danish Medical Products Agency of drug clinical trials].
Jacobsen E; Stilbo I
Ugeskr Laeger; 2003 Apr; 165(16):1656-8. PubMed ID: 12756822
[TBL] [Abstract][Full Text] [Related]
7. [European Marketing Authorisation: a long process. Experiences of small biotech companies with the ATMP regulation].
Buljovčić Z
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2011 Jul; 54(7):831-8. PubMed ID: 21698536
[TBL] [Abstract][Full Text] [Related]
8. [Safety monitoring of cell-based medicinal products (CBMPs)].
Funk MB; Frech M; Spranger R; Keller-Stanislawski B
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1239-46. PubMed ID: 26391098
[TBL] [Abstract][Full Text] [Related]
9. New drug approval process in Japan.
Hayakawa T
Curr Opin Biotechnol; 1999 Jun; 10(3):307-11. PubMed ID: 10361082
[No Abstract] [Full Text] [Related]
10. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].
Jost N; Schüssler-Lenz M; Ziegele B; Reinhardt J
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1207-14. PubMed ID: 26369763
[TBL] [Abstract][Full Text] [Related]
11. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
Iglesias-Lopez C; Obach M; Vallano A; Agustí A
Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
[TBL] [Abstract][Full Text] [Related]
12. [Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].
Dejas-Eckertz P; Schäffner G
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):423-8. PubMed ID: 15830253
[TBL] [Abstract][Full Text] [Related]
13. [Clinical trials with advanced therapy medicinal products].
Schüssler-Lenz M; Schneider CK
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2010 Jan; 53(1):68-74. PubMed ID: 20011994
[TBL] [Abstract][Full Text] [Related]
14. International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice.
Fed Regist; 1998 Sep; 63(185):51074-84. PubMed ID: 10185809
[TBL] [Abstract][Full Text] [Related]
15. Providing Quality Therapeutics in Switzerland: Role of the Stakeholders and Recent Incentives for Further Improvements.
Besson M; Samer C; Rollason V; Dayer P; Desmeules J
Clin Ther; 2015 Jul; 37(7):1588-92. PubMed ID: 26049714
[TBL] [Abstract][Full Text] [Related]
16. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
Salmikangas P; Schuessler-Lenz M; Ruiz S; Celis P; Reischl I; Menezes-Ferreira M; Flory E; Renner M; Ferry N
Adv Exp Med Biol; 2015; 871():103-30. PubMed ID: 26374215
[TBL] [Abstract][Full Text] [Related]
17. [Regulatory framework of innovative therapies : From bench to bedside].
Walter C; Rohde B; Wicke DC; Pohler C; Lührmann A; von der Leyen H
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2011 Jul; 54(7):803-10. PubMed ID: 21698532
[TBL] [Abstract][Full Text] [Related]
18. Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products.
Lucas-Samuel S; Ferry N; Trouvin JH
Adv Exp Med Biol; 2015; 871():73-85. PubMed ID: 26374213
[TBL] [Abstract][Full Text] [Related]
19. [The Innovation Office of the Paul-Ehrlich-Institut. Regulatory support during the scientific development of ATMP].
Ziegele B; Dahl L; Müller AT
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2011 Jul; 54(7):857-66. PubMed ID: 21698540
[TBL] [Abstract][Full Text] [Related]
20. Current regulatory and legal considerations for follow-on biologics.
Kingham RF; Lietzan E
Clin Pharmacol Ther; 2008 Nov; 84(5):633-5. PubMed ID: 18716615
[No Abstract] [Full Text] [Related]
[Next] [New Search]