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Nagai, Sumimasa
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1

Drug approval delays in hematologic malignancies between Eu..:

Matsuda, Kensuke ; Nagai, Sumimasa ; Sugimoto, Koichi
Japanese Journal of Clinical Oncology.  53 (2023)  12 - p. 1125-1129 , 2023
Link: https://doi.org/10.1093/..
 
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2

Tumor mutational burden measurement using comprehensive gen..:

Kage, Hidenori ; Kohsaka, Shinji ; Tatsuno, Kenji...
Japanese Journal of Clinical Oncology.  52 (2022)  8 - p. 925-929 , 2022
Link: https://doi.org/10.1093/..
 
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3

Recommendations related to the analytical equivalence asses..:

Nagai, Sumimasa ; Nishihara, Hiroshi ; Suzuki, Takayoshi...
Cancer Science.  113 (2022)  10 - p. 3282-3290 , 2022
Link: https://doi.org/10.1111/..
 
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4

Biosimilar Epoetin in the United States: A View from the So..:

, In: Cancer Drug Safety and Public Health Policy; Cancer Treatment and Research,
Nagai, Sumimasa ; Witherspoon, Bartlett ; Nabhan, Chadi. - p. 41-51 , 2022
Link: https://doi.org/10.1007/..
 
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5

The First 2 Years of Biosimilar Epoetin for Cancer and Chem..:

Bennett, Charles L. ; Nagai, Sumimasa ; Bennett, Andrew C....
The Oncologist.  26 (2021)  8 - p. e1418-e1426 , 2021
Link: https://doi.org/10.1002/..
 
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6

Flexible and Expedited Regulatory Review Processes for Inno..:

Nagai, Sumimasa
International Journal of Molecular Sciences.  20 (2019)  15 - p. 3801 , 2019
Link: https://doi.org/10.3390/..
 
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7

Addressing the dichotomy between individual and societal ap..:

Salgado, Roberto ; Solit, David B. ; Rimm, David L....
European Journal of Cancer.  114 (2019)  - p. 128-136 , 2019
Link: https://doi.org/10.1016/..
 
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8

Current Trends in Clinical Development of Gene and Cellular..:

Nagai, Sumimasa ; Sugiyama, Daisuke
Clinical Therapeutics.  41 (2019)  1 - p. 174-184.e3 , 2019
Link: https://doi.org/10.1016/..
 
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9

Regulatory and Clinical Experiences with Biosimilar Filgras..:

Chen, Brian ; Nagai, Sumimasa ; Armitage, James O....
The Oncologist.  24 (2019)  4 - p. 537-548 , 2019
Link: https://doi.org/10.1634/..
 
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10

Global Development of Anticancer Therapies for Rare Cancers..:

Lyerly, H. Kim ; Ren, Jun ; Canetta, Renzo...
Journal of Global Oncology.  , 2018
Link: https://doi.org/10.1200/..
 
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11

Drug approval based on randomized phase 3 trials for relaps..:

Nagai, Sumimasa ; Ozawa, Keiya
Investigational New Drugs.  36 (2018)  3 - p. 487-495 , 2018
Link: https://doi.org/10.1007/..
 
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12

Societal challenges of precision medicine: Bringing order t..:

Salgado, Roberto ; Moore, Helen ; Martens, John W.M....
European Journal of Cancer.  84 (2017)  - p. 325-334 , 2017
Link: https://doi.org/10.1016/..
 
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13

Evolving Japanese regulations on companion diagnostics:

Nagai, Sumimasa ; Urata, Masaaki ; Sato, Hiroyuki...
Nature Biotechnology.  34 (2016)  2 - p. 141-144 , 2016
Link: https://doi.org/10.1038/..
 
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14

Comprehensive analysis of clinical development and regulato..:

Nagai, Sumimasa ; Ozawa, Keiya
Investigational New Drugs.  34 (2016)  6 - p. 777-791 , 2016
Link: https://doi.org/10.1007/..
 
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15

Regulatory approval pathways for anticancer drugs in Japan,..:

Nagai, Sumimasa ; Ozawa, Keiya
International Journal of Hematology.  104 (2016)  1 - p. 73-84 , 2016
Link: https://doi.org/10.1007/..
 
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