Búsqueda | Biblioteca Virtual en Salud Odontología. Uruguay

1.

Drug approval delays in hematologic malignancies between Europe and the US and between Japan and the US: a clinical perspective.

Matsuda, Kensuke; Nagai, Sumimasa; Sugimoto, Koichi.

Jpn J Clin Oncol ; 53(12): 1125-1129, 2023 Dec 07.

Artículo en Inglés | MEDLINE | ID: mdl-37642224

2.

Recommendations related to the analytical equivalence assessment of gene panel testing.

Nagai, Sumimasa; Nishihara, Hiroshi; Suzuki, Takayoshi; Nishio, Kazuto; Taniguchi, Hiroya; Tsuchihara, Katsuya; Nakamura, Kohei; Takamatsu, Reika; Ueno, Toshihide; Aburatani, Hiroyuki; Kohno, Takashi; Kohsaka, Shinji.

Cancer Sci ; 113(10): 3282-3290, 2022 Oct.

Artículo en Inglés | MEDLINE | ID: mdl-35906844

3.

Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions.

Nagai, Sumimasa; Witherspoon, Bartlett; Nabhan, Chadi; Bennett, Charles L.

Cancer Treat Res ; 184: 41-51, 2022.

Artículo en Inglés | MEDLINE | ID: mdl-36449186

4.

Tumor mutational burden measurement using comprehensive genomic profiling assay.

Kage, Hidenori; Kohsaka, Shinji; Tatsuno, Kenji; Ueno, Toshihide; Ikegami, Masachika; Zokumasu, Koichi; Shinozaki-Ushiku, Aya; Nagai, Sumimasa; Aburatani, Hiroyuki; Mano, Hiroyuki; Oda, Katsutoshi.

Jpn J Clin Oncol ; 52(8): 925-929, 2022 08 05.

Artículo en Inglés | MEDLINE | ID: mdl-35482395

5.

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions.

Bennett, Charles L; Nagai, Sumimasa; Bennett, Andrew C; Hoque, Shamia; Nabhan, Chadi; Schoen, Martin W; Hrushesky, William J; Luminari, Stefano; Ray, Paul; Yarnold, Paul R; Witherspoon, Bart; Riente, Josh; Bobolts, Laura; Brusk, John; Tombleson, Rebecca; Knopf, Kevin; Fishman, Marc; Yang, Y Tony; Carson, Kenneth R; Djulbegovic, Benjamin; Restaino, John; Armitage, James O; Sartor, Oliver A.

Oncologist ; 26(8): e1418-e1426, 2021 08.

Artículo en Inglés | MEDLINE | ID: mdl-33586299

6.

[Pharmaceutical approval process of drugs for hematological malignancies: current situations in Japan].

Nagai, Sumimasa.

Rinsho Ketsueki ; 61(5): 437-444, 2020.

Artículo en Japonés | MEDLINE | ID: mdl-32507805

7.

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.

Chen, Brian; Nagai, Sumimasa; Armitage, James O; Witherspoon, Bartlett; Nabhan, Chadi; Godwin, Ashley C; Yang, Y Tony; Kommalapati, Anuhya; Tella, Sri Harsha; DeAngelis, Carlo; Raisch, Dennis W; Sartor, Oliver; Hrushesky, William J; Ray, Paul S; Yarnold, Paul R; Love, Bryan L; Norris, LeAnn B; Knopf, Kevin; Bobolts, Laura; Riente, Joshua; Luminari, Stefano; Kane, Robert C; Hoque, Shamia; Bennett, Charles L.

Oncologist ; 24(4): 537-548, 2019 04.

Artículo en Inglés | MEDLINE | ID: mdl-30842244

8.

Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.

Nagai, Sumimasa.

Int J Mol Sci ; 20(15)2019 Aug 03.

Artículo en Inglés | MEDLINE | ID: mdl-31382625

9.

Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases.

Nagai, Sumimasa; Ozawa, Keiya.

Invest New Drugs ; 36(3): 487-495, 2018 06.

Artículo en Inglés | MEDLINE | ID: mdl-29453626

10.

Current situation of oncology biosimilars in Japan.

Nagai, Sumimasa.

Lancet Oncol ; 22(3): e82, 2021 03.

Artículo en Inglés | MEDLINE | ID: mdl-33662290

11.

Generic oncology drugs: are they all safe?

Yang, Y Tony; Nagai, Sumimasa; Chen, Brian K; Qureshi, Zaina P; Lebby, Akida A; Kessler, Samuel; Georgantopoulos, Peter; Raisch, Dennis W; Sartor, Oliver; Hermanson, Terhi; Kane, Robert C; Hrushesky, William J; Riente, Joshua J; Norris, LeAnn B; Bobolts, Laura R; Armitage, James O; Bennett, Charles L.

Lancet Oncol ; 17(11): e493-e501, 2016 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-27819247

12.

Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.

Nagai, Sumimasa; Ozawa, Keiya.

Br J Haematol ; 174(2): 249-54, 2016 07.

Artículo en Inglés | MEDLINE | ID: mdl-27018163

13.

Comprehensive analysis of clinical development and regulatory submission promotion schemes for oncologic drugs as the Japanese national projects.

Nagai, Sumimasa; Ozawa, Keiya.

Invest New Drugs ; 34(6): 777-791, 2016 12.

Artículo en Inglés | MEDLINE | ID: mdl-27538583

14.

Generic drugs in oncology - Authors' reply.

Bennett, Charles L; Nagai, Sumimasa; Yang, Y Tony; Chen, Brian K; Sartor, Oliver; Armitage, James O.

Lancet Oncol ; 18(2): e64, 2017 02.

Artículo en Inglés | MEDLINE | ID: mdl-28214418

15.

Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.

Thanarajasingam, Gita; Minasian, Lori M; Bhatnagar, Vishal; Cavalli, Franco; De Claro, R Angelo; Dueck, Amylou C; El-Galaly, Tarec C; Everest, Neil; Geissler, Jan; Gisselbrecht, Christian; Gormley, Nicole; Gribben, John; Horowitz, Mary; Ivy, S Percy; Jacobson, Caron A; Keating, Armand; Kluetz, Paul G; Kwong, Yok Lam; Little, Richard F; Matasar, Matthew J; Mateos, Maria-Victoria; McCullough, Kristen; Miller, Robert S; Mohty, Mohamad; Moreau, Philippe; Morton, Lindsay M; Nagai, Sumimasa; Nair, Abhilasha; Nastoupil, Loretta; Robertson, Kaye; Sidana, Surbhi; Smedby, Karin E; Sonneveld, Pieter; Tzogani, Kyriaki; van Leeuwen, Flora E; Velikova, Galina; Villa, Diego; Wingard, John R; Seymour, John F; Habermann, Thomas M.

Lancet Haematol ; 9(5): e374-e384, 2022 May.

Artículo en Inglés | MEDLINE | ID: mdl-35483398

16.

Japanese regulatory authority's perspective on biosimilars.

Nagai, Sumimasa; Yanagihara, Reiko; Kishioka, Yasuhiro.

Lancet Oncol ; 16(3): e101, 2015 Mar.

Artículo en Inglés | MEDLINE | ID: mdl-25752552

17.

[Exploratory biomarker analyses and companion diagnostics].

Nagai, Sumimasa.

Nihon Rinsho ; 73 Suppl 2: 126-30, 2015 Feb.

Artículo en Japonés | MEDLINE | ID: mdl-25831736

18.

Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan.

Nagai, Sumimasa; Sugiyama, Daisuke.

Clin Ther ; 41(1): 174-184.e3, 2019 01.

Artículo en Inglés | MEDLINE | ID: mdl-30528048

19.

Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology.

Salgado, Roberto; Solit, David B; Rimm, David L; Bogaerts, Jan; Canetta, Renzo; Lively, Tracy; Lyerly, Kim; Span, Paul N; Bateman-House, Alison; Makady, Amr; Bergmann, L; Nagai, Sumimasa; Smith, Chris; Robson, Mark; Savage, Mary; Voest, Emile; Sweeney, Christopher; Lambin, Philippe; Thomas, Marlene; Harris, Lyndsay; Lacombe, Denis; Massard, Chistophe.

Eur J Cancer ; 114: 128-136, 2019 06.

Artículo en Inglés | MEDLINE | ID: mdl-31060925

20.

The origin of neoplastic mast cells in systemic mastocytosis with AML1/ETO-positive acute myeloid leukemia.

Nagai, Sumimasa; Ichikawa, Motoshi; Takahashi, Tsuyoshi; Sato, Hiroyuki; Yokota, Hiromitsu; Oshima, Kumi; Izutsu, Koji; Hangaishi, Akira; Kanda, Yoshinobu; Motokura, Toru; Chiba, Shigeru; Yatomi, Yutaka; Kurokawa, Mineo.

Exp Hematol ; 35(11): 1747-52, 2007 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-17976525

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Drug approval delays in hematologic malignancies between Europe and the US and between Japan and the US: a clinical perspective.

Recommendations related to the analytical equivalence assessment of gene panel testing.

Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions.

Tumor mutational burden measurement using comprehensive genomic profiling assay.

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions.

[Pharmaceutical approval process of drugs for hematological malignancies: current situations in Japan].

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.

Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.

Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases.

Current situation of oncology biosimilars in Japan.

Generic oncology drugs: are they all safe?

Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.

Comprehensive analysis of clinical development and regulatory submission promotion schemes for oncologic drugs as the Japanese national projects.

Generic drugs in oncology - Authors' reply.

Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.

Japanese regulatory authority's perspective on biosimilars.

[Exploratory biomarker analyses and companion diagnostics].

Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan.

Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology.

The origin of neoplastic mast cells in systemic mastocytosis with AML1/ETO-positive acute myeloid leukemia.