Fang L - Search Results

1

Mechanistic modeling of drug products applied to the skin: A workshop summary report.

Tsakalozou E, Alam K, Ghosh P, Spires J, Polak S, Fang L, Sammeta S, Zhao P, Arora S, Raney SG. Tsakalozou E, et al. Among authors: fang l. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):575-584. doi: 10.1002/psp4.12893. Epub 2022 Dec 1. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36456539 Free PMC article. Review.

2

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. Clin Pharmacol Ther. 2018 Jul;104(1):27-30. doi: 10.1002/cpt.1065. Epub 2018 Mar 30. Clin Pharmacol Ther. 2018. PMID: 29603191

3

A General Framework for Assessing In vitro/In vivo Correlation as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach.

Gomeni R, Fang LL, Bressolle-Gomeni F, Spencer TJ, Faraone SV, Babiskin A. Gomeni R, et al. CPT Pharmacometrics Syst Pharmacol. 2019 Feb;8(2):97-106. doi: 10.1002/psp4.12378. Epub 2019 Feb 5. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 30659771 Free PMC article.

4

Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products.

Basu S, Yang H, Fang L, Gonzalez-Sales M, Zhao L, Trame MN, Lesko L, Schmidt S. Basu S, et al. Among authors: fang l. J Clin Pharmacol. 2019 Sep;59(9):1252-1263. doi: 10.1002/jcph.1017. Epub 2019 May 14. J Clin Pharmacol. 2019. PMID: 31087553

5

Examination of Metoprolol Pharmacokinetics and Pharmacodynamics Across CYP2D6 Genotype-Derived Activity Scores.

Thomas CD, Mosley SA, Kim S, Lingineni K, El Rouby N, Langaee TY, Gong Y, Wang D, Schmidt SO, Binkley PF, Estores DS, Feng K, Kim H, Kinjo M, Li Z, Fang L, Chapman AB, Cooper-DeHoff RM, Gums JG, Hamadeh IS, Zhao L, Schmidt S, Frye RF, Johnson JA, Cavallari LH. Thomas CD, et al. Among authors: fang l. CPT Pharmacometrics Syst Pharmacol. 2020 Dec;9(12):678-685. doi: 10.1002/psp4.12563. Epub 2020 Nov 3. CPT Pharmacometrics Syst Pharmacol. 2020. PMID: 33067866 Free PMC article. Clinical Trial.

6

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.

Lee J, Gong Y, Bhoopathy S, DiLiberti CE, Hooker AC, Rostami-Hodjegan A, Schmidt S, Suarez-Sharp S, Lukacova V, Fang L, Zhao L. Lee J, et al. Among authors: fang l. Clin Pharmacol Ther. 2021 Nov;110(5):1190-1195. doi: 10.1002/cpt.2120. Epub 2020 Dec 29. Clin Pharmacol Ther. 2021. PMID: 33236362 Review.

7

Physiologically-based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate.

Farhan N, Cristofoletti R, Basu S, Kim S, Lingineni K, Jiang S, Brown JD, Fang LL, Lesko LJ, Schmidt S. Farhan N, et al. CPT Pharmacometrics Syst Pharmacol. 2021 Mar;10(3):199-210. doi: 10.1002/psp4.12589. Epub 2021 Feb 10. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 33449439 Free PMC article.

8

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: fang l. 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.

9

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.

Al Shoyaib A, Riedmaier AE, Kumar A, Roy P, Parrott NJ, Fang L, Tampal N, Yang Y, Jereb R, Zhao L, Wu F. Al Shoyaib A, et al. Among authors: fang l. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):610-618. doi: 10.1002/psp4.12913. Epub 2023 Jan 16. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36597353 Free PMC article. Review.

10

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.

Babiskin A, Wu F, Mousa Y, Tan ML, Tsakalozou E, Walenga RL, Yoon M, Raney SG, Polli JE, Schwendeman A, Krishnan V, Fang L, Zhao L. Babiskin A, et al. Among authors: fang l. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):619-623. doi: 10.1002/psp4.12920. Epub 2023 Feb 5. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36631942 Free PMC article. Review.

Save citations to file

Email citations

Send citations to clipboard

Add to Collections

Add to My Bibliography

Create a file for external citation management software

Your saved search

Your RSS Feed

My NCBI Filters

Text availability

Article attribute

Article type

Publication date

7,379 results

Search Page