Zhao L - Search Results

1

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Hu M, Babiskin A, Wittayanukorn S, Schick A, Rosenberg M, Gong X, Kim MJ, Zhang L, Lionberger R, Zhao L. Hu M, et al. Among authors: zhao l. Clin Pharmacol Ther. 2019 Jul;106(1):174-181. doi: 10.1002/cpt.1479. Epub 2019 Jun 12. Clin Pharmacol Ther. 2019. PMID: 31009066

2

The antibody drug absorption following subcutaneous or intramuscular administration and its mathematical description by coupling physiologically based absorption process with the conventional compartment pharmacokinetic model.

Zhao L, Ji P, Li Z, Roy P, Sahajwalla CG. Zhao L, et al. J Clin Pharmacol. 2013 Mar;53(3):314-25. doi: 10.1002/jcph.4. Epub 2013 Feb 20. J Clin Pharmacol. 2013. PMID: 23426855

3

Dissolution Failure of Solid Oral Drug Products in Field Alert Reports.

Sun D, Hu M, Browning M, Friedman RL, Jiang W, Zhao L, Wen H. Sun D, et al. Among authors: zhao l. J Pharm Sci. 2017 May;106(5):1302-1309. doi: 10.1016/j.xphs.2017.01.014. Epub 2017 Jan 17. J Pharm Sci. 2017. PMID: 28104414

4

Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

Zhang X, Duan J, Kesisoglou F, Novakovic J, Amidon GL, Jamei M, Lukacova V, Eissing T, Tsakalozou E, Zhao L, Lionberger R. Zhang X, et al. Among authors: zhao l. CPT Pharmacometrics Syst Pharmacol. 2017 Aug;6(8):492-495. doi: 10.1002/psp4.12204. Epub 2017 Jul 11. CPT Pharmacometrics Syst Pharmacol. 2017. PMID: 28571121 Free PMC article.

5

Model-Based Assessment Using Conventional Bioequivalence Limits to Ensure Safety and Efficacy of Rivaroxaban in Patients Undergoing Hip or Knee Replacement.

González-Sales M, Fang L, Kim MJ, Zhao L. González-Sales M, et al. Among authors: zhao l. J Clin Pharmacol. 2017 Dec;57(12):1591-1599. doi: 10.1002/jcph.930. Epub 2017 Sep 19. J Clin Pharmacol. 2017. PMID: 28926095

6

Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs.

Li Z, Fang L, Jiang W, Kim MJ, Zhao L. Li Z, et al. Among authors: zhao l. Curr Neurol Neurosci Rep. 2017 Sep 19;17(11):82. doi: 10.1007/s11910-017-0795-1. Curr Neurol Neurosci Rep. 2017. PMID: 28929357 Review.

7

Big Data Toolsets to Pharmacometrics: Application of Machine Learning for Time-to-Event Analysis.

Gong X, Hu M, Zhao L. Gong X, et al. Among authors: zhao l. Clin Transl Sci. 2018 May;11(3):305-311. doi: 10.1111/cts.12541. Epub 2018 Mar 13. Clin Transl Sci. 2018. PMID: 29536640 Free PMC article.

8

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.

Fang L, Kim MJ, Li Z, Wang Y, DiLiberti CE, Au J, Hooker A, Ducharme MP, Lionberger R, Zhao L. Fang L, et al. Among authors: zhao l. Clin Pharmacol Ther. 2018 Jul;104(1):27-30. doi: 10.1002/cpt.1065. Epub 2018 Mar 30. Clin Pharmacol Ther. 2018. PMID: 29603191

9

Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance.

Hu M, Jiang X, Absar M, Choi S, Kozak D, Shen M, Weng YT, Zhao L, Lionberger R. Hu M, et al. Among authors: zhao l. AAPS J. 2018 Apr 12;20(3):62. doi: 10.1208/s12248-018-0212-y. AAPS J. 2018. PMID: 29651627

10

Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time.

Walenga RL, Babiskin AH, Zhang X, Absar M, Zhao L, Lionberger RA. Walenga RL, et al. Among authors: zhao l. J Pharm Sci. 2019 Jan;108(1):620-629. doi: 10.1016/j.xphs.2018.10.034. Epub 2018 Oct 29. J Pharm Sci. 2019. PMID: 30385283

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