196 related articles for article (PubMed ID: 20628171)
1. Differences between Japan and the United States in dosages of drugs recently approved in Japan.
Nakashima K; Narukawa M; Kanazu Y; Takeuchi M
J Clin Pharmacol; 2011 Apr; 51(4):549-60. PubMed ID: 20628171
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. Exploring differences in drug doses between Japan and Western countries.
Arnold FL; Kusama M; Ono S
Clin Pharmacol Ther; 2010 Jun; 87(6):714-20. PubMed ID: 20410879
[TBL] [Abstract][Full Text] [Related]
4. Assessment of factors associated with dose differences between Japan and the United States.
Arnold FL; Fukunaga S; Kusama M; Matsuki N; Ono S
Clin Pharmacol Ther; 2014 May; 95(5):542-9. PubMed ID: 24281222
[TBL] [Abstract][Full Text] [Related]
5. Same drug, different dosing: differences in dosing for drugs approved in the United States, Europe, and Japan.
Malinowski HJ; Westelinck A; Sato J; Ong T
J Clin Pharmacol; 2008 Aug; 48(8):900-8. PubMed ID: 18524997
[TBL] [Abstract][Full Text] [Related]
6. Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors.
Ichimaru K; Toyoshima S; Uyama Y
Clin Pharmacol Ther; 2010 Mar; 87(3):362-6. PubMed ID: 20107436
[No Abstract] [Full Text] [Related]
7. Promoting, improving and accelerating the drug development and approval processes.
Graul AI
Drug News Perspect; 2007; 20(1):45-55. PubMed ID: 17332899
[TBL] [Abstract][Full Text] [Related]
8. Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: issues of international harmonization.
O'Neill RT
Stat Med; 1995 May 15-30; 14(9-10):117-27. PubMed ID: 7569506
[TBL] [Abstract][Full Text] [Related]
9. Anticancer drug development from traditional cytotoxic to targeted therapies: evidence of shorter drug research and development time, and shorter drug lag in Japan.
Kawabata-Shoda E; Masuda S; Kimura H
J Clin Pharm Ther; 2012 Oct; 37(5):547-52. PubMed ID: 22428857
[TBL] [Abstract][Full Text] [Related]
10. 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]
11. Industry perspectives on ICH guidelines.
Rockhold FW
Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111
[TBL] [Abstract][Full Text] [Related]
12. Analysis of pharmaceutical safety-related regulatory actions in Japan: do tradeoffs exist between safer drugs and launch delay?
Yamada T; Kusama M; Hirai Y; Arnold F; Sugiyama Y; Ono S
Ann Pharmacother; 2010 Dec; 44(12):1976-85. PubMed ID: 21098757
[TBL] [Abstract][Full Text] [Related]
13. [Globalization of clinical trials].
Akaza H; Fukuoka M; Ohtsu A; Usami M; Ikeda T; Aiba K; Isonishi S; Ohashi Y; Saijo N; Sone S; Tsukagoshi S; Tsuruo T; Kato M; Mikami O; Dong RP; von Euler M; Blackledge G; Stribling D
Gan To Kagaku Ryoho; 2003 Apr; 30(4):555-65. PubMed ID: 12722692
[TBL] [Abstract][Full Text] [Related]
14. Characteriation of clinical data packages using foreign data in new drug applications in Japan.
Tanaka M; Nagata T
Clin Pharmacol Ther; 2008 Sep; 84(3):340-6. PubMed ID: 17786162
[TBL] [Abstract][Full Text] [Related]
15. [Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].
Kock M; Thomsen MK
Ugeskr Laeger; 2003 Apr; 165(16):1649-52. PubMed ID: 12756820
[TBL] [Abstract][Full Text] [Related]
16. Viagra's rise above women's health issues: an analysis of the social and political influences on drug approvals in the United States and Japan.
Hollander I
Soc Sci Med; 2006 Feb; 62(3):683-93. PubMed ID: 16040176
[TBL] [Abstract][Full Text] [Related]
17. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
Davit BM; Nwakama PE; Buehler GJ; Conner DP; Haidar SH; Patel DT; Yang Y; Yu LX; Woodcock J
Ann Pharmacother; 2009 Oct; 43(10):1583-97. PubMed ID: 19776300
[TBL] [Abstract][Full Text] [Related]
18. New drug approval times and 'therapeutic potential' in Canada, Australia, Sweden and the United States during the period 1992 to 1998.
Rawson NS; Kaitin KI
Can J Clin Pharmacol; 2000; 7(2):97-101. PubMed ID: 10958705
[TBL] [Abstract][Full Text] [Related]
19. Lost in translation: differences in antimicrobial indication approval policies between the United States and Europe.
Pappas G; Ierodiakonou V; Falagas ME
Clin Ther; 2009 Jul; 31(7):1595-603. PubMed ID: 19695409
[TBL] [Abstract][Full Text] [Related]
20. Investigation of the relationship between a starting dose in first-in-human studies and no observed adverse effect level in nonclinical studies.
Sato A; Narukawa M
Int J Clin Pharmacol Ther; 2014 Sep; 52(9):770-6. PubMed ID: 25034619
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
