QR-koodi

Cancer registry as external control data for regulatory submission in Japan

Through the Clinical Innovation Network, Japan’s regulatory authorities have enhanced the development of registries that utilize real-world data (RWD). The Ministry of Health, Labour and Welfare has issued guidelines, whereas the Pharmaceuticals and Medical Devices Agency has conducted consultations...

Täydet tiedot

Tallennettuna:
Päätekijät: H. Bando, N. Okita, Y. Sakamoto, H. Sokuoka, Y. Nakamura, T. Hashimoto, T. Misumi, Y. Takeda, Y. Aoyagi, K. Mizuguchi, H.S. Okuma, N. Fuse, K. Yonemori, K. Nakamura, N. Yamamoto, T. Yoshino, A. Ohtsu
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: Elsevier 2024-12-01
Sarja:ESMO Real World Data and Digital Oncology
Aiheet:
external control data
new drug application
real-world data
real-world evidence
data relevancy
data reliability
Linkit:http://www.sciencedirect.com/science/article/pii/S294982012400050X
Tagit: Lisää tagi
Ei tageja, Lisää ensimmäinen tagi!

Samankaltaisia teoksia