Zobrazeno 1 - 10
of 104
pro vyhledávání: '"Mutsuhiro Ikuma"'
Autor:
Yusuke Tanaka, Mototsugu Tanaka, Haruna Miyazawa, Ryohei Terashima, Makoto Miyazawa, Mutsuhiro Ikuma, Yoshihiko Tomita
Publikováno v:
Clinical and Translational Science, Vol 17, Iss 4, Pp n/a-n/a (2024)
Abstract 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 Drug Admin
Externí odkaz:
https://doaj.org/article/9e595c87004749aa867227c952768959
Publikováno v:
Clinical and Translational Science, Vol 16, Iss 8, Pp 1289-1293 (2023)
Externí odkaz:
https://doaj.org/article/f0b7354f669a4b88b147f9acdecdf8b8
Publikováno v:
Clinical and Translational Science, Vol 14, Iss 6, Pp 2339-2347 (2021)
Abstract 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 year are required to b
Externí odkaz:
https://doaj.org/article/4f110dba9e164384af91d02ec52ee583
Autor:
Satoshi Osawa, Takanori Yamada, Takeji Saitoh, Takashi Kosugi, Tomohiro Terai, Yasuhiro Takayanagi, Yasushi Hamaya, Ken Sugimoto, Mutsuhiro Ikuma
Publikováno v:
Case Reports in Gastroenterology, Vol 4, Iss 2, Pp 229-237 (2010)
Severe late toxicity following chemoradiotherapy in esophageal cancer, especially cardiac toxicity, is sometimes difficult to treat and is associated with mortality. However there is little published information with regard to patients with delayed p
Externí odkaz:
https://doaj.org/article/f102bd93893a42049cb1792f2714ae73
Publikováno v:
Clinical and Translational Science, Vol 14, Iss 6, Pp 2339-2347 (2021)
Clinical and Translational Science
Clinical and Translational Science
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 year are required to be include
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3ccabc44ad52f8c470be487b29f90086
https://doaj.org/article/4f110dba9e164384af91d02ec52ee583
https://doaj.org/article/4f110dba9e164384af91d02ec52ee583
Publikováno v:
Clinical Pharmacology & Therapeutics. 111:358-361
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::268519035b9348a02ecc2e9ee0579275
https://doi.org/10.1002/cpt.2275
https://doi.org/10.1002/cpt.2275
Autor:
Shuichi Kawarasaki, Ryosuke Kato, Hiroshi Sakaguchi, Mutsuhiro Ikuma, Kenji Sawanobori, Miki Nakamura, Toshiyuki Hata, Mayumi Idei, Daisuke Sato, Mototsugu Tanaka, Asako Yoshizaki
Publikováno v:
British Journal of Clinical Pharmacology. 87:4027-4035
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 the several advantages in prioritiz
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::334d4086eccde19c0ed75fbc4bf4d01b
https://doi.org/10.1111/bcp.14807
https://doi.org/10.1111/bcp.14807
Autor:
Kenji Sawanobori, Ryosuke Kato, Hiroshi Sakaguchi, Shuichi Kawarasaki, Toshiyuki Hata, Miki Nakamura, Mayumi Idei, Mutsuhiro Ikuma, Daisuke Sato, Mototsugu Tanaka, Asako Yoshizaki
Publikováno v:
Clinical Pharmacology and Therapeutics
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 identify the first-in-world approvals and clarify the current
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1effebe5c0bc4b58c487fb1806604045
https://doi.org/10.1002/cpt.2080
https://doi.org/10.1002/cpt.2080
Autor:
Mutsuhiro Ikuma, Mototsugu Tanaka
Publikováno v:
Kidney international. 100(1)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a19fbc78a0e2ff788bdad7332d467db5
https://pubmed.ncbi.nlm.nih.gov/33637197
https://pubmed.ncbi.nlm.nih.gov/33637197
Autor:
Mutsuhiro Ikuma, Mototsugu Tanaka, Shuichi Kawarasaki, Asako Yoshizaki, Ryosuke Kato, Miki Nakamura, Daisuke Sato, Kenji Sawanobori, Hiroshi Sakaguchi, Toshiyuki Hata, Mayumi Idei
Publikováno v:
British journal of clinical pharmacologyREFERENCES. 87(8)
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 Japan. METHODS Among 80 new drugs first approved in Japan from 2008 to
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::87c8c37ff35041929e7968a2b40fe41c
https://pubmed.ncbi.nlm.nih.gov/33511674
https://pubmed.ncbi.nlm.nih.gov/33511674