170 related articles for article (PubMed ID: 31245506)
1. Bayesian statistics and clinical trial designs for human cells and tissue products for regulatory approval.
Jokura Y; Yano K; Watanabe N; Yamato M
Regen Ther; 2016 Dec; 5():86-95. PubMed ID: 31245506
[TBL] [Abstract][Full Text] [Related]
2. Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan.
Yano K; Watanabe N; Tsuyuki K; Ikawa T; Kasanuki H; Yamato M
Regen Ther; 2015 Jun; 1():45-56. PubMed ID: 31589662
[TBL] [Abstract][Full Text] [Related]
3. Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.
Crider K; Williams J; Qi YP; Gutman J; Yeung L; Mai C; Finkelstain J; Mehta S; Pons-Duran C; Menéndez C; Moraleda C; Rogers L; Daniels K; Green P
Cochrane Database Syst Rev; 2022 Feb; 2(2022):. PubMed ID: 36321557
[TBL] [Abstract][Full Text] [Related]
4. Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.
Kim J; Park J; Song SY; Kim E
Regen Ther; 2022 Jun; 20():126-137. PubMed ID: 35582708
[TBL] [Abstract][Full Text] [Related]
5. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.
Jokura Y; Yano K; Yamato M
J Tissue Eng Regen Med; 2018 Feb; 12(2):e1056-e1062. PubMed ID: 28211195
[TBL] [Abstract][Full Text] [Related]
6. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
[TBL] [Abstract][Full Text] [Related]
7. INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.
Drugs R D; 2007; 8(3):176-87. PubMed ID: 17472413
[TBL] [Abstract][Full Text] [Related]
8. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
Pflieger M; Bertram D
Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
[TBL] [Abstract][Full Text] [Related]
9. Regulatory and clinical development to support the approval of advanced therapies medicinal products in Japan.
Carolina IL; Antònia A; Mercè O; Antonio V
Expert Opin Biol Ther; 2022 Jul; 22(7):831-842. PubMed ID: 35762253
[TBL] [Abstract][Full Text] [Related]
10. The future of Cochrane Neonatal.
Soll RF; Ovelman C; McGuire W
Early Hum Dev; 2020 Nov; 150():105191. PubMed ID: 33036834
[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; Agustà A
Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
[TBL] [Abstract][Full Text] [Related]
12. Japanese regulation of biosimilar products: past experience and current challenges.
Arato T
Br J Clin Pharmacol; 2016 Jul; 82(1):30-40. PubMed ID: 26987746
[TBL] [Abstract][Full Text] [Related]
13. ISA 247: trans-ISA 247, trans-R 1524, ISA(TX)247, ISAtx 247, ISATx247, LX 211, LX211, R 1524, R-1524.
Drugs R D; 2007; 8(2):103-12. PubMed ID: 17324008
[TBL] [Abstract][Full Text] [Related]
14. Erlotinib: CP 358774, NSC 718781, OSI 774, R 1415.
Adis International Ltd
Drugs R D; 2003; 4(4):243-8. PubMed ID: 12848590
[TBL] [Abstract][Full Text] [Related]
15. Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.
Azuma K; Yamanaka S
Regen Ther; 2016 Jun; 4():36-47. PubMed ID: 31245486
[TBL] [Abstract][Full Text] [Related]
16. Iodine-131 Tositumomab: (131)I-anti-B1 antibody, (131)I-tositumomab, anti-CD20 murine monoclonal antibody-I-131, B1, Bexxar, (131)I-anti-B1 antibody, iodine-131 tositumomab, iodine-131 anti-B1 antibody, tositumomab.
BioDrugs; 2003; 17(4):290-5. PubMed ID: 12899647
[TBL] [Abstract][Full Text] [Related]
17. New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.
Nagai S; Ozawa K
Curr Gene Ther; 2017; 17(1):17-28. PubMed ID: 28382858
[TBL] [Abstract][Full Text] [Related]
18. Lessons learned from independent central review.
Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
19. Amoxicillin pulsatile - MiddleBrook: APC 111, APC-111, PULSYS-enhanced amoxicillin.
Drugs R D; 2007; 8(6):395-9. PubMed ID: 17963430
[TBL] [Abstract][Full Text] [Related]
20. Melanoma Vaccine--AVAX Technologies: DNP-VACC, M-Vax.
BioDrugs; 2003; 17(1):69-72. PubMed ID: 12534322
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]