Pan Y - Search Results

1

FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.

Mehta GU, Vellanki PJ, Ren Y, Amatya AK, Mishra-Kalyani PS, Pan L, Zirkelbach JF, Pan Y, Liu J, Aungst SL, Miller CP, Shah M, Rahman NA, Theoret M, Kluetz P, Pazdur R, Beaver JA, Singh H. Mehta GU, et al. Among authors: pan l, pan y. Oncologist. 2024 Aug 5;29(8):667-671. doi: 10.1093/oncolo/oyae151. Oncologist. 2024. PMID: 38970465 Free PMC article. Clinical Trial.

2

FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.

Khozin S, Blumenthal GM, Zhang L, Tang S, Brower M, Fox E, Helms W, Leong R, Song P, Pan Y, Liu Q, Zhao P, Zhao H, Lu D, Tang Z, Al Hakim A, Boyd K, Keegan P, Justice R, Pazdur R. Khozin S, et al. Among authors: pan y. Clin Cancer Res. 2015 Jun 1;21(11):2436-9. doi: 10.1158/1078-0432.CCR-14-3157. Epub 2015 Mar 9. Clin Cancer Res. 2015. PMID: 25754348 Clinical Trial.

3

Quantitative methods and modeling to assess COVID-19-interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches.

Gong Y, Feng K, Zhang P, Lee J, Pan Y, Zhang Z, Ni Z, Bai T, Yoon M, Li B, Kim CY, Fang L, Zhao L. Gong Y, et al. Among authors: pan y. CPT Pharmacometrics Syst Pharmacol. 2022 Jul;11(7):833-842. doi: 10.1002/psp4.12795. Epub 2022 Apr 20. CPT Pharmacometrics Syst Pharmacol. 2022. PMID: 35411692 Free PMC article.

4

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.

Wagner C, Zhao P, Pan Y, Hsu V, Grillo J, Huang SM, Sinha V. Wagner C, et al. Among authors: pan y. CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):226-30. doi: 10.1002/psp4.33. Epub 2015 Apr 17. CPT Pharmacometrics Syst Pharmacol. 2015. PMID: 26225246 Free PMC article.

5

Predicting the Effect of CYP3A Inducers on the Pharmacokinetics of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK Submissions to the US FDA.

Wagner C, Pan Y, Hsu V, Sinha V, Zhao P. Wagner C, et al. Among authors: pan y. Clin Pharmacokinet. 2016 Apr;55(4):475-83. doi: 10.1007/s40262-015-0330-y. Clin Pharmacokinet. 2016. PMID: 26369776

6

The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives.

Pan Y, Hsu V, Grimstein M, Zhang L, Arya V, Sinha V, Grillo JA, Zhao P. Pan Y, et al. J Clin Pharmacol. 2016 Jul;56 Suppl 7:S122-31. doi: 10.1002/jcph.740. J Clin Pharmacol. 2016. PMID: 27385170 Review.

7

Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status.

Li M, Zhao P, Pan Y, Wagner C. Li M, et al. Among authors: pan y. CPT Pharmacometrics Syst Pharmacol. 2018 Feb;7(2):82-89. doi: 10.1002/psp4.12260. Epub 2017 Nov 23. CPT Pharmacometrics Syst Pharmacol. 2018. PMID: 29168611 Free PMC article. Review.

8

Predictive Performance of Physiologically-Based Pharmacokinetic Models in Predicting Drug-Drug Interactions Involving Enzyme Modulation.

Hsueh CH, Hsu V, Pan Y, Zhao P. Hsueh CH, et al. Among authors: pan y. Clin Pharmacokinet. 2018 Oct;57(10):1337-1346. doi: 10.1007/s40262-018-0635-8. Clin Pharmacokinet. 2018. PMID: 29455429

9

Bioequivalence Study Methods with Pharmacokinetic Endpoints for Topical Ophthalmic Corticosteroid Suspensions and Effects of Subject Demographics.

Harigaya Y, Jiang X, Zhang H, Chandaroy P, Stier EM, Pan Y. Harigaya Y, et al. Among authors: pan y. Pharm Res. 2018 Nov 15;36(1):13. doi: 10.1007/s11095-018-2537-8. Pharm Res. 2018. PMID: 30443681

10

Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration.

Wagner C, Pan Y, Hsu V, Grillo JA, Zhang L, Reynolds KS, Sinha V, Zhao P. Wagner C, et al. Among authors: pan y. Clin Pharmacokinet. 2015 Jan;54(1):117-27. doi: 10.1007/s40262-014-0188-4. Clin Pharmacokinet. 2015. PMID: 25260695

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