Zobrazeno 1 - 10
of 196
pro vyhledávání: '"Tsutomu Matsuda"'
Publikováno v:
Pharmacoepidemiology and drug safety. 27(11)
PURPOSE To determine if concerns toward adverse reactions (ARs) identified during the drug approval process are associated with their post-approval addition to package inserts. METHODS Pre-approval concerns toward 24 target ARs were identified in the
Autor:
Takahiro Kinoshita, Takashi Kawakami, Kenichi Yamazaki, Tsutomu Matsuda, Tomoya Sugiura, Naohiro Furukawa
Publikováno v:
The Proceedings of the Materials and Mechanics Conference. 2015:GS0111-26
Publikováno v:
Pharmacoepidemiology and Drug Safety. 24:166-175
Purpose The aim of this study was to quantitatively analyze clinically significant adverse reactions (CSARs) added to drug package inserts after approval and to investigate the time to these post-approval additions as an indicator of safety-related r
Publikováno v:
Pharmaceutical Medicine. 28:7-19
Introduction Drug Safety Communications (DSCs), a major tool for risk communication used by the US Food and Drug Administration (FDA), are also designed to encourage spontaneous reporting. However, the effectiveness of this tool remains unclear.
Publikováno v:
Pharmaceutical Medicine. 26:395-403
Drug agencies and pharmaceutical companies are responsible for continuously monitoring drug safety profiles to implement necessary safety measures. Retrospective analyses of safety-related regulatory actions (SRRAs) are known to be helpful as a tool
Autor:
Takeo Nakayama, Hisashi Urushihara, Hiroki Sugimori, Gen Kobashi, Hideaki Masuda, Tsutomu Matsuda, Michiko Yamamoto, Setsuko Taneichi, Koji Kawakami, Kaori Ohta
Publikováno v:
SpringerPlus
In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, th
Autor:
Tsutomu Matsuda, Toshio Ichihara, Mitsuaki Kitano, Hideki Wanibuchi, Tomoyuki Shirai, Susumu Imaoka, Shoji Fukushima, Seiko Tamano, Yoshihiko Funae, Akihiro Hagiwara
Publikováno v:
Carcinogenesis. 19:1475-1480
The dose dependence of the hepatopromoting effects of phenobarbital (PB) was investigated in a rat liver medium-term bioassay (Ito test) to elucidate a practical threshold level. F344 rats were given a single i.p. injection of diethylnitrosamine (200
Autor:
Susumu Makino, Setsuko Machino, Tadao Oohara, Motoko Hosono, Akira Takashima, Hirofumi Yamashita, Satoru Mori, Shoji Fukushima, Hideki Wanibuchi, Takashi Murai, Tsutomu Matsuda
Publikováno v:
Japanese Journal of Cancer Research : Gann
Rat strain differences in sensitivity to the promoting effect of sodium L-ascorbate (SA) on the development of urinary bladder tumors were investigated. In experiment 1, WS/Shi (WS), ODS/Shiod/od (ODS), and LEW/Crj (LEW) rats were initiated with 0.05
Publikováno v:
Journal of Toxicologic Pathology. 10:153-156
Variation and location of cytochrome P450 isoenzyme expression in various organs of male F344 rats treated with 1, 2-dimethylhydrazine (DMH), N, N-dibutylnitrosamine (DBN), and methylbenzylnitrosamine (MBNA) were immunohisto-chemically and biochemica
Publikováno v:
Pharmacoepidemiology and drug safety. 24(2)
The aim of this study was to quantitatively analyze clinically significant adverse reactions (CSARs) added to drug package inserts after approval and to investigate the time to these post-approval additions as an indicator of safety-related regulator