Ye J - Search Results

1

Considerations for master protocols using external controls.

Chen J, Li XN, Lu CC, Yuan S, Yung G, Ye J, Tian H, Lin J. Chen J, et al. Among authors: ye j. J Biopharm Stat. 2024 Feb 16:1-23. doi: 10.1080/10543406.2024.2311248. Online ahead of print. J Biopharm Stat. 2024. PMID: 38363805

2

How to select the initial dose for a pediatric study?

Ye J, Bi Y, Ting N. Ye J, et al. J Biopharm Stat. 2023 Nov 2;33(6):844-858. doi: 10.1080/10543406.2022.2149770. Epub 2022 Dec 8. J Biopharm Stat. 2023. PMID: 36476267

3

Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges.

Choi Y, Barbier N, Fürst-Recktenwald S, Ye J, Wajsbrot DB, Ishida E, Gamalo M. Choi Y, et al. Among authors: ye j. J Biopharm Stat. 2023 Nov 2;33(6):786-799. doi: 10.1080/10543406.2022.2154357. Epub 2022 Dec 21. J Biopharm Stat. 2023. PMID: 36541817

4

Clinical trial considerations for pediatric cancer drug development.

Cooner F, Ye J, Reaman G. Cooner F, et al. Among authors: ye j. J Biopharm Stat. 2023 Nov 2;33(6):859-874. doi: 10.1080/10543406.2023.2172424. Epub 2023 Feb 7. J Biopharm Stat. 2023. PMID: 36749066

5

Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US.

Ye J, Zhang V, Strimenopoulou F, Zhao Y, Pan H, Shabbout M, Gamalo M. Ye J, et al. J Biopharm Stat. 2023 Nov 2;33(6):681-695. doi: 10.1080/10543406.2023.2170407. Epub 2023 Feb 7. J Biopharm Stat. 2023. PMID: 36751009 Review.

6

Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects.

Gamalo M, Zhao Y, Gao A, Ye J, Lin J, Eshida E, Choi Y, Nelson R. Gamalo M, et al. Among authors: ye j. J Biopharm Stat. 2023 Nov 2;33(6):770-785. doi: 10.1080/10543406.2023.2172425. Epub 2023 Feb 26. J Biopharm Stat. 2023. PMID: 36843283

7

Tumor-Agnostic Approvals: Insights and Practical Considerations.

Lu CC, Beckman RA, Li XN, Zhang W, Jiang Q, Marchenko O, Sun Z, Tian H, Ye J, Yuan SS, Yung G; Master Protocol subteam of the Statistical Methods in Oncology Scientific Working Group, Biopharmaceutical Session, American Statistical Association. Lu CC, et al. Among authors: ye j. Clin Cancer Res. 2024 Feb 1;30(3):480-488. doi: 10.1158/1078-0432.CCR-23-1340. Clin Cancer Res. 2024. PMID: 37792436

8

A Bayesian approach in design and analysis of pediatric cancer clinical trials.

Ye J, Reaman G, De Claro RA, Sridhara R. Ye J, et al. Pharm Stat. 2020 Nov;19(6):814-826. doi: 10.1002/pst.2039. Epub 2020 Jun 14. Pharm Stat. 2020. PMID: 32537913

9

Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics.

Li Y, Nelson R, Izem R, Broglio K, Mundayat R, Gamalo M, Wen Y, Pan H, Sun H, Ye J. Li Y, et al. Among authors: ye j. Ther Innov Regul Sci. 2024 Apr 23. doi: 10.1007/s43441-024-00656-z. Online ahead of print. Ther Innov Regul Sci. 2024. PMID: 38653950 Review.

10

An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits.

Kilaru R, Amodio S, Li Y, Wells C, Love S, Zeng Y, Ye J, Jelizarow M, Balakumar A, Fronc M, Osterdal AS, Rolfe T, Talbot S. Kilaru R, et al. Among authors: ye j. Ther Innov Regul Sci. 2024 Mar;58(2):273-284. doi: 10.1007/s43441-023-00598-y. Epub 2023 Dec 26. Ther Innov Regul Sci. 2024. PMID: 38148473 Free PMC article. Review.

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