Work

Translation of FDA Draft Guidance on Externally Controlled Trials: Enhancing Real-World Evidence in Regulatory Science

Year: 2025

Type: article

Abstract: Hee-Jin Seo, Yunju Choe, Jeong-Eun Lee, Ju Hwan Kim, Ji Won Kim, Gyeongmin Lim, Woo Hyeon Yoo, YongHyun Cho, Byungsun Yoon, Sungpil Han, Dong Keon Yon and Ju-Young Shin. Pharmacoepidemiology and Risk Management 2025;17:123-35. https://doi.org/10.56142/perm.25.0015

Source: Journal of Pharmacoepidemiology and Risk Management

DOI: 10.56142/perm.25.0015

Authors: Hee-Jin Seo, Yunju Choe, Jeong-Eun Lee, Ju Hwan Kim, Ji Won Kim, Gyeongmin Lim, Woo Hyeon Yoo, YongHyun Cho, Byungsun Yoon, Sungpil Han, Dong Keon Yon, Ju-Young Shin

Institutions: Sungkyunkwan University, Kakao Corporation (South Korea), Catholic University of Korea, Kyung Hee University

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Funders: Ministry of Health and Welfare, Korea Health Industry Development Institute, Ministry of Science and ICT, South Korea

Awards: G1499063997, G5681772784, G7849113112

OpenAlex ID: W7083445503

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