Mutsuhiro Ikuma
Overview
Explore the profile of Mutsuhiro Ikuma including associated specialties, affiliations and a list of published articles.
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Articles
54
Citations
582
Followers
0
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Recent Articles
1.
Miyazawa M, Tanaka M, Tanaka Y, Terashima R, Ezura M, Miyazawa H, et al.
Clin Pharmacol Ther
. 2024 Nov;
117(2):544-553.
PMID: 39513521
New drug applications (NDAs) in Japan are reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA). Those that pass the review are subsequently subject to deliberation by the Ministry of...
2.
Tanaka Y, Tanaka M, Miyazawa H, Terashima R, Miyazawa M, Ikuma M, et al.
Clin Transl Sci
. 2024 Apr;
17(4):e13803.
PMID: 38651283
Drug safety communications (DSCs) are essential tools for communicating important postmarket serious drug safety information to healthcare professionals and patients. Previous studies characterized DSCs issued by the U.S. Food and...
3.
Tanaka M, Miyazawa H, Terashima R, Ikuma M
Clin Transl Sci
. 2023 May;
16(8):1289-1293.
PMID: 37161871
No abstract available.
4.
5.
Uzu S, Sekine S, Asano J, Ikuma M
Clin Transl Sci
. 2021 Jun;
14(6):2339-2347.
PMID: 34121342
Under the International Council for Harmonization (ICH)-E1 guideline for drugs intended for chronic or repeated intermittent use in non-life-threatening diseases, data from 100 patients exposed for a minimum of 1 ...
6.
Tanaka M, Ikuma M, Asakura W, Fujiwara Y
Clin Pharmacol Ther
. 2021 May;
111(2):358-361.
PMID: 33993499
No abstract available.
7.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al.
Br J Clin Pharmacol
. 2021 Mar;
87(10):4027-4035.
PMID: 33694268
The Sakigake designation system (Sakigake) has been launched to encourage the pioneered development of innovative new medical products for the effective treatment of severe illness in Japan, which allows leveraging...
8.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al.
Br J Clin Pharmacol
. 2021 Jan;
87(8):3279-3291.
PMID: 33511674
Aims: To clarify the rationales of delay or difference in the review of new drug applications among regulatory authorities for new drugs, those first approved in the world being in...
9.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al.
Clin Pharmacol Ther
. 2020 Oct;
109(5):1265-1273.
PMID: 33048367
The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and...
10.
Tanaka M, Shinohara K, Ono A, Ikuma M
J Am Soc Nephrol
. 2020 Sep;
31(11):2737.
PMID: 32897870
No abstract available.