Publications
2012
Publications
Ishibashi T, Kusama M, Sugiyama Y, Ono S.
Analysis of regulatory review times of new drugs in Japan: Association with characteristics of new drug applications, regulatory agency, and pharmaceutical companies.
J. Clin. Pharm. Ther. (in press)
Hirai Y, Yamanaka Y, Kusama M, Ishibashi T, Sugiyama Y, Ono S.
Analysis of success rates and the delay of development in Japan.
Health Policy. 104:241-6;2012 (http://dx.doi.org/10.1016/j.healthpol.2011.11.008)
Kusama M, Akazawa M, Tsutani K
A survey on hospital formulary development in Japan: Transitions over the past ten years.
Jpn J Clin Pharmacol Ther. 43:43-9;2012
Presentations
●Annual Meeting of the Pharmaceutical Society of Japan (132th; 2012/03)
Chang CH, Kusama M, Akazawa M, Orii T, Ohta K.
"Pharmacoepidemiology study of myopathy risk related to statin use and drug-drug interaction" (Poster[Japanese]) (PDF)）
2011
Publications
Yokota M, Kusama M, Sugiyama Y, Ono S.
Analysis of labeling decisions on therapeutic indication during new drug reviews in Japan.
Clin Pharmacol Ther. 90:432-441;2011. (doi:10.1038/clpt.2011.134)
Fukunaga S, Kusama M, Arnold FL, Ono S.
Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan.
J Clin Pharmacol. 51:1237-1240;2011. (doi:10.1177/0091270010381500)
Presentations
●Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (32th; 2011/12)
Ishibashi T, Fukushima T, Sugiyama Y, Ono S.
"Analysis of factors associated with the length of regulatory review and the applicant's registration stragety"(Poster[Japanese])（PDF)
Yamanaka Y, Hirai Y, Hizume T, Ono S (Shinya), Kusama M, Sugiyama Y, Ono S.
"Recent trends in drug-lag and the underlying mechanisms" (Poster[Japanese]) (PDF)
Takeuchi S, Kusama M, Sugiyama Y, Ono S.
"Factors affecting causality assessment of adverse event in clinical trials" (poster)（PDF)
●International Conference on Pharmacoepidemiology & Therapeutic Risk Management (27th; 2011/08)
Kusama M, Yanagisawa Y, Sakakibara M, Igarashi A, Akazawa M.
"Intensive education program by community pharmacists to improve adherence to self-management in type 2 diabetes" (Poster)（PDF）
●Annual Meeting of the Pharmaceutical Society of Japan (131th; 2011/03)
Yamanaka Y, Hirai Y, Ono Shinya, Hizume T, Kusama M, Sugiyama Y, Ono S.
"Global clinical development programs and the contribution of Japan"(Poster[Japanese]) (PDF)
2010
Publications
Yamada T, Kusama M, Hirai Y, Arnold FL, Sugiyama Y, Ono S.
Analysis of pharmaceutical safety-related regulatory actions in Japan: Do tradeoffs exist between safer drugs and launch delay?
Ann Pharmacother. 44:1976-85;2010. (doi:10.1345/aph.1P153)
Ishibashi T, Yasuda K, Kusama M, Sugiyama Y, Ono S.
Clinical development and review times for new drugs in Japan: associated factors.
Clin Pharmacol Ther. 88:487-491;2010.(doi:10.1038/clpt.2010.108)
Kusama M, Toshimoto K, Maeda K, Hirai Y, Imai S, Chiba K, Akiyama Y, Sugiyama Y.
In silico classification of major clearance pathways of drugs with their physiochemical parameters.
Drug Metab Dispos. 38:1362-70;2010. (doi:10.1124/dmd.110.032789)
Arnold FL, Kusama M, Ono S.
Exploring differences in drug doses between Japan and Western countries.
Clin Pharmacol Ther. 87:714-20;2010. (doi:10.1038/clpt.2010.31)
Hirai Y, Kinoshita H, Kusama M, Yasuda K, Sugiyama Y, Ono S.
Delays in new drug applications in Japan and industrial R&D strategies.
Clin Pharmacol Ther. 87:212-8;2010. (doi:10.1038/clpt.2009.215)
Presentations
●Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (31th; 2010/12)
Konishi K, Kusama M, Ono S, Sugiyama Y.
"Ethnic differences of AEs observed in clinical trials of new drugs" (Poster[Japanese]) (PDF)
Yokota M, Kusama M, Ono S, Sugiyama Y.
"Changes in therapeutic indications before and after new drug reviews in Japan"(Poster[Japanese]) (PDF)
Takamoto M, Kusama M, Ono S, Sugiyama Y.
"Investigation on factors associated with labeling changes in Japan" (Poster[Japanese]) (PDF)
Yamada T, Kusama M, Hirai Y, Ono S, Sugiyama Y.
"What factors are associated with numbers of ADR reports?" (Poster[Japanese]) (PDF)
●Annual Meeting of the Pharmaceutical Society of Japan (130th; 2010/03)
Chen F, Kusama M, Tsutani K.
"Comparison of post-marketing ADR/AE reporting systems in China, Japan and USA" (Poster) (PDF)
2009
Publications
Kusama M, Maeda K, Chiba K, Aoyama A, Sugiyama Y.
Prediction of the effects of genetic polymorphism on the pharmacokinetics of CYP2C9 substrates from in vitro data.
Pharm Res. 26:822-35;2009. (doi:10.1007/s11095-008-9781-2)
Presentations
●Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (30th; 2009/12)
Arnold FL, Kusama M, Fukunaga S, Ono S, Sugiyama Y.
"International comparison of approved doses in Japan and US" (Poster[Japanese]) (PDF)
Fukunaga S, Arnold FL, Kusama M, Ono S, Sugiyama Y.
"Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan" (Poster[Japanese]) (PDF)
Yamada T, Kusama M, Hirai Y, Arnold FL, Ono S, Sugiyama Y.
"Quantative analysis on safety related regulatory actions and accumulation of safety data" (Poster[Japanese]) (PDF)
Ishibashi T, Ono S
"Globalization of new drug development and review in Japan" (Poster[Japanese]) (PDF)
●Annual Meeting of the Pharmaceutical Society of Japan (129th; 2009/03)
Kudo K, Nakamura M, Yagi T, Kusama M, Ono S, Sugiyama Y.
"How comfortable is "drug lag" in Japan for the industry?" (Poster[Japanese]) (PDF)
●The International Meeting for Promotion of Global Clinical Development IN TOKYO (2009/02)
Arnold FL, Kusama M, Ono S, Sugiyama Y.
"Exploring the diversity in approved doses of Japan, US, and Europe" (Slides [Japanese]) (PDF)
2008
●Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (29th; 2008/12)
Hirai Y, Kinoshita H, Kusama M, Yasuda K, Ishibashi K, Ono S, Sugiyama Y.
"Quantitative analysis on "drug-lag" in Japan: factors associated with delays in filing new drugs" (Poster[Japanese]) (PDF)
Arnold FL, Kusama M, Kodama Y, Ono S, Sugiyama Y.
"Investigation on the differences in approved doses of Japan and US" (Poster[Japanese]) (PDF)
●Annual Meeting of the Pharmaceutical Society of Japan (128th; 2008/03)
Arnold FL, Kusama M, Ono S, Sugiyama Y.
"Investigation on the differences in approved doses of Japan and US" (Poster[Japanese]) (PDF)
"Exploring international dose differences" (Highlited Poster[Japanese]) (PDF)
2007
●Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (28th; 2007/12)
Kinoshita H, Ono S, Yasuda K, Kodama Y, Kusama M, Sugiyama Y.
"The use of foreign clinical data in Japanese drug filing" (Poster[Japanese]) (PDF)