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Frontiers in Medicine
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April 30, 2025
Accelerated therapeutic development during COVID-19: insights, regulatory strategies, and recommendations for future pandemic preparedness
Miyuki Katayama, Mayumi Shikano
Therapeutic Innovation & Regulatory Science
|
June 20, 2020
Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation
Eiji Kajiwara, Mayumi Shikano
BMJ Open
|
September 12, 2025
Accelerating clinical development outside the usual regions for future pandemics: a comparative analysis of COVID-19 therapeutic development between the USA and Japan
Miyuki Katayama, Mayumi Shikano
Therapeutic Innovation & Regulatory Science
|
September 1, 2020
Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan
Eiji Kajiwara, Haruki Kamizato, Mayumi Shikano
Vaccines
|
October 27, 2022
Points to Consider in the Development and Information Provision of Vaccines for Vaccination during Pregnancy: A Survey
Yumiko Nomura, Yuusuke Oohashi, Mayumi Shikano
Therapeutic Innovation & Regulatory Science
|
June 7, 2021
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies
Eiji Kajiwara, Haruki Kamizato, Mayumi Shikano
BMC Pediatrics
|
April 13, 2025
Clinical data required for the approval of pediatric pharmaceuticals in Japan
Hisamitsu Haigo, Kenji Matsuda, Mayumi Shikano
Vaccine
|
January 10, 2024
Issues with infectious disease vaccine introduction into routine vaccination in Japan, and considerations for accelerating the process
Atsuko Okumoto, Yumiko Nomura, Shin Okuda, et al.
Clinical and Translational Science
|
June 19, 2026
Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA
Takahiro Handa, Arata Tanaka, Mayumi Shikano, et al.
BMJ Open
|
October 11, 2023
Implementation status and consideration for the globalisation of decentralised clinical trials: a cross-sectional analysis of clinical trial databases
Takahiro Sato, Shota Mizumoto, Midori Ota, et al.
Page
of 3
Search research articles
Search
Showing results (1-10 of 28) with videos related to
Sort By:
Page
of 3
Frontiers in Medicine
|
April 30, 2025
Accelerated therapeutic development during COVID-19: insights, regulatory strategies, and recommendations for future pandemic preparedness
Miyuki Katayama, Mayumi Shikano
Therapeutic Innovation & Regulatory Science
|
June 20, 2020
Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation
Eiji Kajiwara, Mayumi Shikano
BMJ Open
|
September 12, 2025
Accelerating clinical development outside the usual regions for future pandemics: a comparative analysis of COVID-19 therapeutic development between the USA and Japan
Miyuki Katayama, Mayumi Shikano
Therapeutic Innovation & Regulatory Science
|
September 1, 2020
Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan
Eiji Kajiwara, Haruki Kamizato, Mayumi Shikano
Vaccines
|
October 27, 2022
Points to Consider in the Development and Information Provision of Vaccines for Vaccination during Pregnancy: A Survey
Yumiko Nomura, Yuusuke Oohashi, Mayumi Shikano
Therapeutic Innovation & Regulatory Science
|
June 7, 2021
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies
Eiji Kajiwara, Haruki Kamizato, Mayumi Shikano
BMC Pediatrics
|
April 13, 2025
Clinical data required for the approval of pediatric pharmaceuticals in Japan
Hisamitsu Haigo, Kenji Matsuda, Mayumi Shikano
Vaccine
|
January 10, 2024
Issues with infectious disease vaccine introduction into routine vaccination in Japan, and considerations for accelerating the process
Atsuko Okumoto, Yumiko Nomura, Shin Okuda, et al.
Clinical and Translational Science
|
June 19, 2026
Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA
Takahiro Handa, Arata Tanaka, Mayumi Shikano, et al.
BMJ Open
|
October 11, 2023
Implementation status and consideration for the globalisation of decentralised clinical trials: a cross-sectional analysis of clinical trial databases
Takahiro Sato, Shota Mizumoto, Midori Ota, et al.
Page
of 3