S. Nagai

发表

New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.

K. Ozawa, S. Nagai, 2017, Current gene therapy.

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

J. Gribben, F. Cavalli, T. Habermann, 2022, The Lancet. Haematology.

The impact of molecularly targeted therapies upon the understanding of leukemogenesis and the role of hematopoietic stem cell transplantation in acute promyelocytic leukemia.

M. Kurokawa, Tsuyoshi Takahashi, S. Nagai, 2010, Current stem cell research & therapy.

Elevated serum levels of soluble interleukin-2 receptor in chronic eosinophilic leukemia/hypereosinophilic syndrome with FIP1L1-PDGFRα fusion gene

M. Kurokawa, K. Izutsu, T. Motokura, 2008, International journal of hematology.

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

Y. Kanda, M. Kurokawa, K. Izutsu, 2007, Experimental hematology.

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

J. Armitage, P. Yarnold, K. Knopf, 2019, The oncologist.

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

K. Ozawa, S. Nagai, 2016, Investigational New Drugs.

Regulatory approval pathways for anticancer drugs in Japan, the EU and the US

K. Ozawa, S. Nagai, 2016, International Journal of Hematology.

Presumptive treatment strategy for aspergillosis in allogeneic haematopoietic stem cell transplant recipients.

Y. Kanda, M. Kurokawa, K. Izutsu, 2007, The Journal of antimicrobial chemotherapy.

Arsenic-induced pericardial and pleural effusion without acute promyelocytic leukemia differentiation syndrome.

M. Kurokawa, Y. Nannya, K. Kumano, 2010, Leukemia research.

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

K. Ozawa, S. Nagai, 2016, British journal of haematology.

Japanese regulatory authority's perspective on biosimilars.

S. Nagai, Reiko Yanagihara, Y. Kishioka, 2015, The Lancet. Oncology.

How should we prevent hematologic relapse of acute promyelocytic leukemia?

M. Kurokawa, Tsuyoshi Takahashi, S. Nagai, 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

J. Gribben, F. Cavalli, T. Habermann, 2018, The Lancet. Haematology.

Generic oncology drugs: are they all safe?

J. Armitage, C. Bennett, D. Raisch, 2016, The Lancet. Oncology.

Generic drugs in oncology - Authors' reply.

J. Armitage, C. Bennett, O. Sartor, 2017, The Lancet. Oncology.

Global Development of Anticancer Therapies for Rare Cancers, Pediatric Cancers, and Molecular Subtypes of Common Cancers

H. Katayama, H. Lyerly, G. Reaman, 2018, Journal of global oncology.

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

P. Lambin, D. Lacombe, P. Span, 2019, European journal of cancer.

Molecular or cytogenetic monitoring and preemptive therapy for central nervous system relapse of acute promyelocytic leukemia

M. Kurokawa, Y. Nannya, S. Arai, 2010, Haematologica.

C. Bennett, Z. Qureshi, S. Nagai, 2019, JAMA oncology.

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.

J. Armitage, P. Yarnold, K. Knopf, 2021, The oncologist.

Maintenance and preemptive therapy with ganciclovir for cytomegalovirus colitis with extremely high antigenemia in adult T-cell leukemia

Kazuya Sato, K. Ozawa, M. Mori, 2009, International journal of hematology.

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

K. Ozawa, S. Nagai, 2018, Investigational New Drugs.

Simultaneous appearance of methotrexate-associated lymphoproliferative disorder and tuberculous meningitis demonstrating the definitive role of immunosuppression

M. Kurokawa, K. Izutsu, Takuro Watanabe, 2009, Annals of Hematology.

The race and dose of chemotherapy should be considered for optimizing maintenance therapy for acute promyelocytic leukemia.

M. Kurokawa, Y. Nannya, A. Hangaishi, 2009, Leukemia research.

Risk-adapted maintenance therapy for acute promyelocytic leukemia.

M. Kurokawa, Tsuyoshi Takahashi, S. Nagai, 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

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

Sumimasa Nagai, S. Nagai, 2019, International journal of molecular sciences.

Analysis of Drugs for Hematological Malignancy That Were Granted Accelerated Approval and Feasibility of Randomized Phase 3 Clinical Trials for Relapsed and Refractory Hematological Malignancy

K. Ozawa, S. Nagai, 2016 .

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

D. Sugiyama, S. Nagai, 2019, Clinical therapeutics.

Simultaneous appearance of central nervous system relapse and subarachnoid hemorrhage during the treatment for acute promyelocytic leukemia

S. Aoki, K. Ohtomo, Y. Kanda, 2008, Annals of Hematology.