Sun W - Search Results

1

New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling.

Loingeville F, Bertrand J, Nguyen TT, Sharan S, Feng K, Sun W, Han J, Grosser S, Zhao L, Fang L, Möllenhoff K, Dette H, Mentré F. Loingeville F, et al. Among authors: sun w. AAPS J. 2020 Oct 30;22(6):141. doi: 10.1208/s12248-020-00507-3. AAPS J. 2020. PMID: 33125589

2

Ratio of means vs. difference of means as measures of superiority, noninferiority, and average bioequivalence.

Sun W, Grosser S, Tsong Y. Sun W, et al. J Biopharm Stat. 2017;27(2):338-355. doi: 10.1080/10543406.2016.1265536. Epub 2016 Dec 6. J Biopharm Stat. 2017. PMID: 27922340

3

Estimation of causal effects in clinical endpoint bioequivalence studies in the presence of intercurrent events: noncompliance and missing data.

Lou Y, Jones MP, Sun W. Lou Y, et al. Among authors: sun w. J Biopharm Stat. 2019;29(1):151-173. doi: 10.1080/10543406.2018.1489408. Epub 2018 Jul 11. J Biopharm Stat. 2019. PMID: 29995564

4

Statistical considerations and impact of the FDA draft guidance for assessing adhesion with transdermal delivery systems and topical patches for ANDAs.

Sun W, Grosser S, Kim C, Raney SG. Sun W, et al. J Biopharm Stat. 2019;29(5):952-970. doi: 10.1080/10543406.2019.1657440. Epub 2019 Sep 8. J Biopharm Stat. 2019. PMID: 31495266

5

Assessing the ratio of means as a causal estimand in clinical endpoint bioequivalence studies in the presence of intercurrent events.

Lou Y, Jones MP, Sun W. Lou Y, et al. Among authors: sun w. Stat Med. 2019 Nov 30;38(27):5214-5235. doi: 10.1002/sim.8367. Epub 2019 Oct 17. Stat Med. 2019. PMID: 31621943

6

Applications of Adaptive Designs in Generic Drug Development.

Lee J, Feng K, Xu M, Gong X, Sun W, Kim J, Zhang Z, Wang M, Fang L, Zhao L. Lee J, et al. Among authors: sun w. Clin Pharmacol Ther. 2021 Jul;110(1):32-35. doi: 10.1002/cpt.2050. Epub 2020 Oct 14. Clin Pharmacol Ther. 2021. PMID: 32940349 No abstract available.

7

Comments on "Statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study".

Sun W, Schuirmann DJ, Grosser S. Sun W, et al. Pharm Stat. 2022 Nov;21(6):1366-1367. doi: 10.1002/pst.2255. Epub 2022 Jul 20. Pharm Stat. 2022. PMID: 35856573 Clinical Trial. No abstract available.

8

Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies.

Guhl M, Mercier F, Hofmann C, Sharan S, Donnelly M, Feng K, Sun W, Sun G, Grosser S, Zhao L, Fang L, Mentré F, Comets E, Bertrand J. Guhl M, et al. Among authors: sun w, sun g. J Pharmacokinet Pharmacodyn. 2022 Oct;49(5):557-577. doi: 10.1007/s10928-022-09821-z. Epub 2022 Sep 16. J Pharmacokinet Pharmacodyn. 2022. PMID: 36112338 Free PMC article.

9

Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studies.

Tardivon C, Loingeville F, Donnelly M, Feng K, Sun W, Sun G, Grosser S, Zhao L, Fang L, Mentré F, Bertrand J. Tardivon C, et al. Among authors: sun w, sun g. CPT Pharmacometrics Syst Pharmacol. 2023 Jul;12(7):904-915. doi: 10.1002/psp4.12960. Epub 2023 Apr 27. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 37114321 Free PMC article.

10

Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.

Herndon TM, Ausin C, Brahme NN, Schrieber SJ, Luo M, Andrada FC, Kim C, Sun W, Zhou L, Grosser S, Yim S, Ricci MS. Herndon TM, et al. Among authors: sun w. PLoS One. 2023 Oct 3;18(10):e0292231. doi: 10.1371/journal.pone.0292231. eCollection 2023. PLoS One. 2023. PMID: 37788264 Free PMC article.

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