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Feasibility of gastric endoscopic submucosal dissection in elderly patients aged≥80 years

World Journal of Gastrointestinal Endoscopy 2022年第1期14卷 49-62页

作者： Yasuhiro Inokuchi Ayaka Ishida Kei Hayashi Yoshihiro Kaneta Hayato Watanabe kazuki kano Mitsuhiro Furuta Kosuke Takahashi Hirohito Fujikawa Takanobu Yamada Kouji Yamamoto Nozomu Machida Takashi Ogata Takashi Oshima Shin Maeda Department of Gastroenterology Kanagawa Cancer CenterYokohama 241-8515KanagawaJapan Department of Gastrointestinal Surgery Kanagawa Cancer CenterYokohama 241-8515KanagawaJapan Department of Biostatics Yokohama City University School of Medicine.Yokohama 236-0004KanagawaJapan Department of Gastroenterology Yokohama City UniversityYokohama 236-0004KanagawaJapan

BACKGROUND Endoscopic resection,especially endoscopic submucosal dissection(ESD),is increasingly performed in elderly patients with early gastric cancer,and lesions beyond the expanded indications are also resected endoscopically in some *** is essential to assess whether gastric ESD is safe and suitable for elderly patients and investigate what type of lesions carry an increased risk of ESD-related *** To assess the efficacy and feasibility of gastric ESD for elderly patients,and define high-risk lesions and prognostic *** Among a total of 1169 sessions of gastric ESD performed in Kanagawa Cancer Center Hospital from 2006 to 2014,179 sessions(15.3%)were performed in patients aged≥80 years,and 172 of these sessions were done in patients with a final diagnosis of gastric *** patients were studied retrospectively to evaluate short-term outcomes and *** short-term outcomes included the rates of en bloc resection and curative resection,complications,and procedurerelated *** was assessed according to the Japanese Gastric Cancer Treatment Guidelines ***’s exact test was used to statistically analyze risk *** characteristics of each group were compared using Fisher’s exact test and Mann-Whitney U *** rates at each time point were based on Kaplan-Meier *** survival rates were compared between patients with gastric cancer in each group with use of the log-rank *** identify prognostic factors that jointly predict the hazard of death while controlling for model overfitting,we used the least absolute shrinkage and selection operator(LASSO)Cox regression model including factors curative/noncurative,age,gender,body mass index,prognostic nutritional index,Charlson comorbidity index(CCI),Glasgow prognostic score,neutrophil-to-lymphocyte ratio,and antithrombotic agent *** selected the LASSO Cox regression model that resulted in minimal prediction error in 10-f

关键词： Endoscopic submucosal dissection Elderly Charlson comorbidity index Early gastric cancer Complications Prognostic indicators

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Control strategy and methods for continuous direct compression processes

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Asian Journal of Pharmaceutical Sciences 2021年第2期16卷 253-262页

作者： Yasuhiro Suzuki Hirokazu Sugiyama Manabu kano Ryutaro Shimono Gosuke Shimada Ryoichi Furukawa Eichi Mano Keiichi Motoyama Tatsuo Koide Yasuhiro Matsui kazuki Kurasaki Issei Takayama Shunin Hikage Noriko Katori Masahiko Kikuchi Hiroshi Sakai Yoshihiro Matsuda Formulation Technology Research Laboratories Daiichi Sankyo Co.Ltd.Kanagawa 254-0014Japan Department of Chemical System Engineering The University of TokyoTokyo 113-8656Japan Department of Systems Science Kyoto UniversityKyoto 606-8501Japan CMC Sciences Department Regulatory Affairs DivisionR&D DivisionJanssen Pharmaceutical K.K.Tokyo 101-0065Japan EuroTechno Ltd. Kanagawa 223-0057Japan Pharmaceutical Research Department Mitsubishi Tanabe Pharma CorporationOsaka 532-8505Japan Chemical Products CMC Regulatory Affairs Area Japan DevelopmentMSD K.K.Tokyo 102-8667Japan Graduate School of Pharmaceutical Sciences Kumamoto UniversityKumamoto 862-0973Japan Division of Drugs National Institute of Health SciencesKawasaki 210-9501Japan Technology Research&Development Sumitomo Dainippon Pharma Co.Ltd.Osaka 564-0053Japan Formulation Development Department Chugai pharmaceutical Co.Ltd.Tokyo 115-8543Japan Office of New Drug IV Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan Office of Generic Drugs Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan KOKANDO Co. Ltd.Toyama 930-8580Japan Pharmaceuticals and Medical Devices Agency Shin-Kasumigaseki Bldg.Tokyo 100-0013Japan

We presented a control strategy for tablet manufacturing processes based on continuous direct *** work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in *** different items in the process,the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch *** control and management of the Loss in Weight(LIW)feeder were deemed the most important,and the Residence Time Distribution(RTD)model were regarded effective for setting the control range and for controlling of the LIW *** on these ideas,the concept of process control using RTD was summarized.

关键词： Continuous manufacturing Solid drug products Process control Residence time distribution Loss in weight feeder Regulatory science

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