383 related articles for article (PubMed ID: 29361305)
1. Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan.
Rokuda M; Matsumaru N; Tsukamoto K
Clin Ther; 2018 Feb; 40(2):284-295. PubMed ID: 29361305
[TBL] [Abstract][Full Text] [Related]
2. [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]
3. Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials.
Ushijima S; Matsumaru N; Tsukamoto K
Pharmaceut Med; 2021 Jul; 35(4):253-260. PubMed ID: 34291425
[TBL] [Abstract][Full Text] [Related]
4. Efaproxiral: GSJ 61, JP 4, KDD 86, RS 4, RSR 13.
Drugs R D; 2005; 6(3):178-85. PubMed ID: 15869322
[TBL] [Abstract][Full Text] [Related]
5. Delays in new drug applications in Japan and industrial R&D strategies.
Hirai Y; Kinoshita H; Kusama M; Yasuda K; Sugiyama Y; Ono S
Clin Pharmacol Ther; 2010 Feb; 87(2):212-8. PubMed ID: 19940847
[TBL] [Abstract][Full Text] [Related]
6. Different Development Strategies Affecting Japan's Drug lag between Japan-Based and Foreign-Based Companies.
Hidaka M; Hanaoka H; Uyama Y
Ther Innov Regul Sci; 2024 Jul; 58(4):714-720. PubMed ID: 38575785
[TBL] [Abstract][Full Text] [Related]
7. Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks.
Tsukamoto K; Carroll KA; Onishi T; Matsumaru N; Brasseur D; Nakamura H
Clin Ther; 2016 Mar; 38(3):574-81. PubMed ID: 26869192
[TBL] [Abstract][Full Text] [Related]
8. Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia.
Noguchi A; Hanaoka H; Uyama Y
Ther Innov Regul Sci; 2022 May; 56(3):523-529. PubMed ID: 35181842
[TBL] [Abstract][Full Text] [Related]
9. Approaches to Japanese dose evaluation in global drug development: factors that generate different dosages between Japan and the United States.
Nakashima K; Narukawa M; Takeuchi M
Clin Pharmacol Ther; 2011 Dec; 90(6):836-43. PubMed ID: 22048222
[TBL] [Abstract][Full Text] [Related]
10. 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]
11. Recent trends and success factors in reducing the lag time to approval of new drugs in Japan.
Honig PK
Clin Pharmacol Ther; 2014 May; 95(5):467-9. PubMed ID: 24747231
[TBL] [Abstract][Full Text] [Related]
12. Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products.
Desai KG; Obayashi H; Colandene JD; Nesta DP
J Pharm Sci; 2018 Jul; 107(7):1773-1786. PubMed ID: 29601839
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. Analysis of Pediatric Drug Approval Lag in Japan.
Ueyama E; Kaneko M; Narukawa M
Ther Innov Regul Sci; 2021 Mar; 55(2):336-345. PubMed ID: 32959206
[TBL] [Abstract][Full Text] [Related]
15. [Delays in clinical development of neurological drugs in Japan].
Ikeda M
Rinsho Shinkeigaku; 2017 Jun; 57(6):274-279. PubMed ID: 28552868
[TBL] [Abstract][Full Text] [Related]
16. [Development of antituberculous drugs: current status and future prospects].
Tomioka H; Namba K
Kekkaku; 2006 Dec; 81(12):753-74. PubMed ID: 17240921
[TBL] [Abstract][Full Text] [Related]
17. Pediatric Drug Development in Japan: A Comparison of the Current Situation and Characteristics Between Japan and Europe.
Ueyama E; Kaneko M; Narukawa M
Ther Innov Regul Sci; 2020 Sep; 54(5):1152-1158. PubMed ID: 32865796
[TBL] [Abstract][Full Text] [Related]
18. Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?
Abraham J; Reed T
Soc Sci Med; 2003 Jul; 57(2):195-204. PubMed ID: 12765701
[TBL] [Abstract][Full Text] [Related]
19. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2015 Jan; 80(17):4282-3. PubMed ID: 25730921
[TBL] [Abstract][Full Text] [Related]
20. [Implementation of the Latest Scientific Knowledge/Technologies and Activities for International Harmonisation of the Japanese Pharmacopoeia].
Ando T; Osawa T
Yakugaku Zasshi; 2020; 140(6):763-766. PubMed ID: 32475924
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
