Appropriate Relevancy and Reliability of Real-World Data for the Utilization of Regulatory Submission-Reference-Cited by-同舟云学术

Appropriate Relevancy and Reliability of Real-World Data for the Utilization of Regulatory Submission

Published:2024-06 Issue:2 Volume:23 Page:111-117
ISSN:1533-0028
Container-title:Clinical Colorectal Cancer
language:en
Short-container-title:Clinical Colorectal Cancer

Author:

Bando Hideaki^ORCID,Misumi Toshihiro,Sakamoto Yasutoshi,Takeda Yuriko,Nakamura Yoshiaki,Mizuguchi Kazuya,Aoyagi Yoshihiro,Miki Izumi,Kuroda Tomohiro,Kasai Ryu,Suzuki Takuya,Yoshino Takayuki,Ohtsu Atsushi

Funder

Chugai Pharmaceuticals Co Ltd

Eisai Co Ltd

Eisai Canada

Government of Japan Ministry of Health Labour and Welfare

Publisher

Elsevier BV

Reference20 articles.

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3. Innovation in the pharmaceutical industry: new estimates of R&D costs;DiMasi;J Health Econ,2016

4. Medical review(S) (BLINCYTO®),2014

5. European Medicines Agency. (2018). Assessment Report (KYMRIAH®). https://www.ema.europa.eu/en/medicines/human/EPAR/kymriah. Accessed: April 1, 2024.

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1. Cancer registry as external control data for regulatory submission in Japan;ESMO Real World Data and Digital Oncology;2024-12