Publications



2014

Publications

Fukunaga S, Kusama M, Matsuki N, Ono.
The effect size, study design, and development experience in commercially sponsored studies for new drug applications in approved drugs.
SpringerPlus. 3:740;2014 (DOI: 10.1186/2193-1801-3-740)

Arnold FL, Fukunaga S, Kusama M, Matsuki N, Ono S.
Assessment of Factors associated with dose differences between Japan and the US.
Clin Pharm Ther. 95:542-549;2014 (DOI: 10.1038/clpt.2013.231)

Presentations

Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (35th;2014/12)

Kamikawa N, Kusama M, Ono S.
Pediatric drug lag in Japan under global drug development strategies(Poster[Jpn])iPDF)


Nobuyama N, Kusama M, Ono S.
Drug development pathways and drug lag in Japan(Poster[Jpn])iPDF)


Yanagisawa M, Kusama M, Ono S.
Mechanisms of drug evaluation and pricing(Poster[Jpn])iPDF)


Hoshikawa K, Kusama M, Ono S.
Benefit-risk assessment in multiple-criteria decision analysis(MCDA) (Poster[Jpn])iPDF)


International Conference on Pharmacoepidemiology & Therapeutic Risk Management (30th ICPE; 2014/10)

Kusama M, Zeniya S, Fukuoka K, Akazawa M.
What makes prescribers switch to fixed-dose combination therapy for Japanese hypertensive patients? (poster)iPDFj



2013

Publications

Yokota M, Kusama M, Matsuki N, Ono S.
Different contributions of internal reviewers and external experts to labeling decisions on therapeutic indications in new drug reviews in Japan.
J Clin Pharm Ther. 38:456-461;2013 (DOI: 10.1111/jcpt.12086)

Chang CH, Kusama M, Ono S, Sugiyama Y, Orii T, and Akazawa M.
Assessment of statin-associated muscle toxicity in Japan: A cohort study conducted using a claims database and laboratory information.
BMJ Open 2013;3:e002040 (DOI:10.1136/bmjopen-2012-002040)

Yamada T, Watanabe Y, Kusama M, Sugiyama Y, Ono S.
Factors associated with spontaneous reporting of adverse drug reactions in Japan.
Pharmacoepidemiol Drug Saf. 22:468-76;2013 (DOI: 10.1002/pds.3378)


Presentations

Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (35th;2013/12)

Kumazawa K, Kusama M, Ono S.
Factors associated with the first revision of drug labels"(Poster[Jpn])iPDF)


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. 37:657-63;2012 (DOI: 10.1111/j.1365-2710.2012.01363.x)

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 (doi: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.(Japanese)
Jpn J Clin Pharmacol Ther. 43:43-9;2012



Presentations

Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (33rd; 2012/11-12)

Hizume T, Kusama M, Matsuki N, Ono S.
How are clinical data packages in NDAs constructed? (Oral [Eng])iPDF)


Fukunaga S, Kusama M, Matsuki N, Ono S.
An analysis of factors associated with the effect size in outcomes of approved products (Poster[Jpn]) (PDF)


Kumazawa K, Kusama M, Sugiyama Y, Ono S.
Ranking of serious adverse reactions in Japanese package inserts (Poster[Jpn])iPDF)



DIA Japan Annual Meeting (9th; 2011/11)

Yamanaka Y, Kusama M, Matsuki N, Ono S.
Time Lag in the Initiatioin of Clinical Development in Japan, US and Europe (Poster [Jpn])iPDF)


Hizume T, Kusama M, Matsuki N, Ono S.
How are clinical data packages in NDAs constructed? (Poster [Jpn])iPDF)



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[Jpn]) (PDF)j




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 [Jpn])iPDF)


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 [Jpn])iPDF)


Takeuchi S, Kusama M, Sugiyama Y, Ono S.
Factors affecting causality assessment of adverse event in clinical trials (Poster [Jpn])iPDF)



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 [Eng])iPDF)


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 [Jpn])iPDF)



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 [Jpn])iPDF)


Yokota M, Kusama M, Ono S, Sugiyama Y.
Changes in therapeutic indications before and after new drug reviews in Japan (Poster [Jpn])iPDF)


Takamoto M, Kusama M, Ono S, Sugiyama Y.
Investigation on factors associated with labeling changes in Japan (Poster [Jpn])iPDF)


Yamada T, Kusama M, Hirai Y, Ono S, Sugiyama Y.
What factors are associated with numbers of ADR reports? (Poster [Jpn])iPDF)


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 [Jpn])iPDF)



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 [Jpn])iPDF)


Fukunaga S, Arnold FL, Kusama M, Ono S, Sugiyama Y.
Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan (Poster [Jpn])iPDF)


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 [Jpn])iPDF)


Ishibashi T, Ono S
"Globalization of new drug development and review in Japan (Poster [Jpn])iPDF)


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 [Jpn])iPDF)

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 [Jpn])iPDF)



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 [Jpn])iPDF)


Arnold FL, Kusama M, Kodama Y, Ono S, Sugiyama Y.
Investigation on the differences in approved doses of Japan and US (Poster [Jpn])iPDF)


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 [Jpn])iPDF)
"Exploring international dose differences (Highlight poster [Jpn])iPDF)



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[Jpn]) (PDF)



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