Search Results - "Iida, Satofumi"

A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A by Yoneyama, Koichiro, Schmitt, Christophe, Kotani, Naoki, Levy, Gallia G., Kasai, Ryu, Iida, Satofumi, Shima, Midori, Kawanishi, Takehiko

“…Background Emicizumab (ACE910) is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII. In phase I–I/II studies,…”
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A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed? by Chiba, Koji, Yoshitsugu, Hiroyuki, Kyosaka, Yuto, Iida, Satofumi, Yoneyama, Koichiro, Tanigawa, Takahiko, Fukushima, Takashi, Hiraoka, Masaki

“…Ethnic evaluation of the pharmacokinetics and safety of new drugs is required in Japan before implementing bridging or joining global studies. As therapeutic…”
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Risk of CYP2C9 induction analyzed by a relative factor approach with human hepatocytes by Endo-Tsukude, Chihiro, Kato, Motohiro, Kaneko, Akihisa, Iida, Satofumi, Kuramoto, Shino, Ishigai, Masaki, Hamada, Akinobu

“…By using the Relative Factor (RF) method—a method that can simply assess cytochrome P450 (CYP) induction risk based on a maximum induction effect model—we…”
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Modeling and Simulation of Orlistat to Predict Weight Loss and Weight Maintenance in Obesity Patients by Nakai, Kiyohiko, Wada, Russell, Iida, Satofumi, Kawanishi, Takehiko, Matsumoto, Yoshiaki

“…Orlistat is used clinically worldwide as anti-obesity drug. It is a chemically synthesized hydrogenated derivative of lipstatin and is an inhibitor of gastric…”
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Population Pharmacokinetic-Pharmacodynamic Modeling and Simulation of Platelet Decrease Induced by Peg-interferon-alpha 2a by Saito, Tomohisa, Iida, Satofumi, Kawanishi, Takehiko

“…Peg-interferon-alpha-2a (PEG-IFN) has been used all over the world including Japan as the standard of care for chronic hepatitis C (CHC). PEG-IFN causes…”
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Dosage Optimization of Nemolizumab Using Population Pharmacokinetic and Pharmacokinetic‐Pharmacodynamic Modeling and Simulation by Saito, Tomohisa, Iida, Satofumi, Terao, Kimio, Kumagai, Yuji

“…Nemolizumab is a humanized anti‐interleukin‐31 receptor A monoclonal antibody for treating atopic dermatitis, and it especially improves pruritus. The…”
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Application of Modeling and Simulation to a Long-Term Clinical Trial: A Direct Comparison of Simulated Data and Data Actually Observed in Japanese Osteoporosis Patients Following 3-Year Ibandronate Treatment by Nakai, Kiyohiko, Iida, Satofumi, Tobinai, Masato, Hashimoto, Junko, Kawanishi, Takehiko

“…Ibandronate, a nitrogen-containing bisphosphonate, is a bone resorption inhibitor widely used to prevent and treat osteoporosis. To optimize the design for a…”
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Erratum to: Application of Modeling and Simulation to a Long-Term Clinical Trial: A Direct Comparison of Simulated Data and Data Actually Observed in Japanese Osteoporosis Patients Following 3-Year Ibandronate Treatment by Nakai, Kiyohiko, Iida, Satofumi, Tobinai, Masato, Hashimoto, Junko, Kawanishi, Takehiko

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The optimal oral dose selection of ibandronate in Japanese patients with osteoporosis based on pharmacokinetic and pharmacodynamic properties by Nakai, Kiyohiko, Tobinai, Masato, Hashimoto, Junko, Iida, Satofumi, Kawanishi, Takehiko

“…Ibandronate is a drug widely used outside Japan for the treatment of osteoporosis. It is available in formulations for intermittent intravenous (i.v.)…”
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Maxacalcitol Pharmacokinetic-Pharmacodynamic Modeling and Simulation for Secondary Hyperparathyroidism in Patients Receiving Maintenance Hemodialysis by Fukazawa-Shinotsuka, Mizuki, Saito, Tomohisa, Abe, Masaichi, Iida, Satofumi, Wang, I-Ting, Terao, Kimio, Chen, Hsi-Hsien, Liu, Ming-Che

“…Maxacalcitol was approved in Taiwan in 2018 as the first active vitamin D3 injection for secondary hyperparathyroidism (SHPT) in patients on maintenance…”
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Indications for a ceftriaxone dosing regimen in Japanese paediatric patients using population pharmacokinetic/pharmacodynamic analysis and simulation by Iida, Satofumi, Kawanishi, Takehiko, Hayashi, Masahiro

“…Objectives  The objective of this study was to build a ceftriaxone population pharmacokinetic model for Japanese paediatric patients and to examine the dosing…”
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Effective use of modeling and simulation in designing bioequivalence and comparability studies of large-molecule compounds: the case of erythropoietin by Nakai, Kiyohiko, Miyata, Kumiko, Iida, Satofumi, Kawanishi, Takehiko

“…Bioequivalence and comparability studies are necessary for changing formulations of large-molecule drugs, such as antibody drugs and protein products, and in…”
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Time‐to‐event modelling of effect of codrituzumab on overall survival in patients with hepatocellular carcinoma by Nakamura, Mikiko, Xu, Chao, Diack, Cheikh, Ohishi, Norihisa, Lee, Ruey‐min, Iida, Satofumi, Kawanishi, Takehiko, Ohtomo, Toshihiko, Abou‐Alfa, Ghassan K., Chen, Ya‐Chi

“…Aims Codrituzumab (GC33) is a recombinant, humanized mAb that binds to glypican‐3 (GPC3), an oncofetal protein highly expressed in hepatocellular carcinoma…”
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A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?: The Journal of Clinical Pharmacology by Chiba, Koji, Yoshitsugu, Hiroyuki, Kyosaka, Yuto, Iida, Satofumi, Yoneyama, Koichiro, Tanigawa, Takahiko, Fukushima, Takashi, Hiraoka, Masaki

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Population pharmacokinetic-pharmacodynamic modelling and simulation of neutropenia induced by TP300, a novel topoisomerase I inhibitor by Saito, Tomohisa, Iida, Satofumi, Abe, Masaichi, Jones, Keith, Kawanishi, Takehiko, Twelves, Chris

“…Objectives TP300 is a novel topoisomerase I inhibitor with neutropenia as a significant toxicity. We developed and evaluated a pharmacokinetic–pharmacodynamic…”
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Population pharmacokinetic and pharmacodynamic modelling of the effects of nicorandil in the treatment of acute heart failure by Iida, Satofumi, Kinoshita, Haruki, Holford, Nicholas H. G.

“…WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Nicorandil injection is used for unstable angina and for acute heart failure in Japan. • The pharmacokinetics of…”
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The pharmacokinetics of ceftriaxone based on population pharmacokinetics and the prediction of efficacy in Japanese adults by Iida, Satofumi, Kinoshita, Haruki, Kawanishi, Takehiko, Hayashi, Masahiro

“…Summary Objective: By using a population pharmacokinetic analysis method, we predicted the efficacy of Ceftriaxone (CTRX) based on the pharmacokinetics of CTRX…”
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Validation Studies of Radioluminography II A Method for Monitoring Radioactive Contamination of Imaging Plates by BABA, Shigeo, ASAHARA, Nobumitsu, IIDA, Satofumi, TATEISHI, Mitsuru, MIYAZAKI, Hiroshi

“…A simple method for monitoring radioactive contamination of imaging plates (IP) was proposed. IPs to be examined (IPEX) were exposed under a standardized…”
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Validation Studies of Radioluminography I: Measurement of Background Value by BABA, Shigeo, ASAHARA, Nobumitsu, IIDA, Satofumi, TOMISAWA, Hiroki, TATEISHI, Mitsuru, MIYAZAKI, Hiroshi

“…A basic study was carried out in order to improve the detection accuracy of radioluminography (RLG) in drug evaluation studies. Back ground value of…”
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Disposition of Q-35. (1). Absorption and Excretion after Single Administration of 14C-Q-35 in Rats by ISHIGAI, Masaki, NAKAGAWA, Toshito, IIDA, Satofumi, OKUTOMI, Tsuneo, OHKUBO, Kazumi, OKAZAKI, Akira

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