Wang W - Search Results

1

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle.

Hendrickson BA, Wang W, Ball G, Bennett D, Bhattacharyya A, Fries M, Kuebler J, Kurek R, McShea C, Tremmel L. Hendrickson BA, et al. Among authors: wang w. Ther Innov Regul Sci. 2021 Jul;55(4):717-732. doi: 10.1007/s43441-021-00271-2. Epub 2021 Mar 23. Ther Innov Regul Sci. 2021. PMID: 33755928

2

Statistical Practices of Safety Monitoring: An Industry Survey.

Colopy MW, Gordon R, Ahmad F, Wang WW, Duke SP, Ball G. Colopy MW, et al. Among authors: wang ww. Ther Innov Regul Sci. 2019 May;53(3):293-300. doi: 10.1177/2168479018779973. Epub 2018 Jul 10. Ther Innov Regul Sci. 2019. PMID: 29991276

3

Interdisciplinary Safety Evaluation and Quantitative Safety Monitoring: Introduction to a Series of Papers.

Seltzer JH, Li J, Wang W. Seltzer JH, et al. Among authors: wang w. Ther Innov Regul Sci. 2019 Mar 29:2168479018793130. doi: 10.1177/2168479018793130. Online ahead of print. Ther Innov Regul Sci. 2019. PMID: 30925080

4

Bridging blinded and unblinded analysis for ongoing safety monitoring and evaluation.

Lin LA, Zhan Y, Li H, Yuan SS, Ball G, Wang W. Lin LA, et al. Among authors: wang w. Contemp Clin Trials. 2019 Aug;83:81-87. doi: 10.1016/j.cct.2019.06.022. Epub 2019 Jun 29. Contemp Clin Trials. 2019. PMID: 31260790

5

Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.

Ball G, Kurek R, Hendrickson BA, Buchanan J, Wang WW, Duke SP, Bhattacharyya A, Li M, O'Brien D, Weigel J, Wang W, Jiang Q, Ahmad F, Seltzer JH, Herrero-Martinez E, Tremmel L. Ball G, et al. Among authors: wang w, wang ww. Ther Innov Regul Sci. 2020 Mar;54(2):447-461. doi: 10.1007/s43441-019-00076-4. Epub 2020 Jan 6. Ther Innov Regul Sci. 2020. PMID: 32072595 Free PMC article.

6

Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making.

Lin LA, Zhang Y, Straus W, Wang W. Lin LA, et al. Among authors: wang w. Ther Innov Regul Sci. 2022 May;56(3):423-432. doi: 10.1007/s43441-021-00349-x. Epub 2022 Feb 9. Ther Innov Regul Sci. 2022. PMID: 35138577 Clinical Trial.

7

A nested group sequential framework for regional evaluation in global drug development program.

Wang W, Jiang Z, Qiu J, Xia J, Guo X. Wang W, et al. J Biopharm Stat. 2017;27(6):945-962. doi: 10.1080/10543406.2017.1293079. Epub 2017 Mar 21. J Biopharm Stat. 2017. PMID: 28323515

8

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

Li K, Yuan SS, Wang W, Wan SS, Ceesay P, Heyse JF, Mt-Isa S, Luo S. Li K, et al. Among authors: wang w. Contemp Clin Trials. 2018 Apr;67:100-108. doi: 10.1016/j.cct.2018.02.016. Epub 2018 Mar 2. Contemp Clin Trials. 2018. PMID: 29505866 Free PMC article.

9

Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity.

Li G, Quan H, Lan G, Ouyang SP, Chen F, Robieson W, Wang W, Binkowitz B, Yuan SS, Tanaka Y, Chen J, Matsuoka N, Zhang L, Yang S, Gallo P. Li G, et al. Among authors: wang w. Ther Innov Regul Sci. 2020 Jan;54(1):21-31. doi: 10.1007/s43441-019-00025-1. Epub 2020 Jan 6. Ther Innov Regul Sci. 2020. PMID: 32008228 Review.

10

Efficient methods for signal detection from correlated adverse events in clinical trials.

Diao G, Liu GF, Zeng D, Wang W, Tan X, Heyse JF, Ibrahim JG. Diao G, et al. Among authors: wang w. Biometrics. 2019 Sep;75(3):1000-1008. doi: 10.1111/biom.13031. Epub 2019 Mar 29. Biometrics. 2019. PMID: 30690717 Free PMC article.

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