Maxfield K - Search Results

1

A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration.

Wang L, Maxfield K, Guinn D, Madabushi R, Zineh I, Schuck RN. Wang L, et al. Among authors: maxfield k. Clin Pharmacol Ther. 2021 Jan;109(1):123-130. doi: 10.1002/cpt.2068. Epub 2020 Nov 15. Clin Pharmacol Ther. 2021. PMID: 33022770 Free PMC article.

2

Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology.

Bruno R, Jin JY, Maxfield K, Milligan L, Liu C, Wang Y, McKee AE, Zineh I. Bruno R, et al. Among authors: maxfield k. Clin Pharmacol Ther. 2019 Jul;106(1):81-83. doi: 10.1002/cpt.1421. Epub 2019 Apr 5. Clin Pharmacol Ther. 2019. PMID: 30951201 No abstract available.

3

Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development.

Thway TM, Wang YM, Booth BP, Maxfield K, Huang SM, Zineh I. Thway TM, et al. Among authors: maxfield k. AAPS J. 2019 Dec 19;22(1):15. doi: 10.1208/s12248-019-0397-8. AAPS J. 2019. PMID: 31858313

4

Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use.

Madabushi R, Pfuma Fletcher E, Florian J, Milligan L, Ramamoorthy A, Yang X, Maxfield K, Sahre M, Jean D, Zhang L, Green D, Zineh I. Madabushi R, et al. Among authors: maxfield k. Clin Pharmacol Ther. 2020 Oct;108(4):710-715. doi: 10.1002/cpt.1849. Epub 2020 May 19. Clin Pharmacol Ther. 2020. PMID: 32430963 Free PMC article.

5

Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting.

Maxfield K, Milligan L, Wang L, Gonzalez D, Johnson-Williams B, Liu Q, Madabushi R, Powell R, Wang Y, Zhu H, Zineh I. Maxfield K, et al. Clin Pharmacol Ther. 2021 Jan;109(1):25-28. doi: 10.1002/cpt.1933. Epub 2020 Jul 14. Clin Pharmacol Ther. 2021. PMID: 32663324 Free PMC article. Review. No abstract available.

6

Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.

Guinn D, Madabushi R, Wang YM, Zineh I, Maxfield K. Guinn D, et al. Among authors: maxfield k. Clin Pharmacol Ther. 2021 Mar;109(3):697-704. doi: 10.1002/cpt.2038. Epub 2020 Sep 28. Clin Pharmacol Ther. 2021. PMID: 32895941

7

Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation.

Guinn D, Madabushi R, Wang YM, Brodsky E, Zineh I, Maxfield K. Guinn D, et al. Among authors: maxfield k. Ther Innov Regul Sci. 2020 Nov;54(6):1363-1371. doi: 10.1007/s43441-020-00161-z. Epub 2020 May 16. Ther Innov Regul Sci. 2020. PMID: 33258100

8

Precision Dosing: A Clinical and Public Health Imperative.

Maxfield K, Zineh I. Maxfield K, et al. JAMA. 2021 Apr 20;325(15):1505-1506. doi: 10.1001/jama.2021.1004. JAMA. 2021. PMID: 33760028 No abstract available.

9

Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments.

Belov AA, Rodriguez Messan M, Yogurtcu ON, Schultz K, Maxfield K, Thompson L, Revell S, Warren-Henderson Y, Tegenge MA, Sauna ZE, Forshee RA. Belov AA, et al. Among authors: maxfield k. Clin Pharmacol Ther. 2023 Feb;113(2):221-225. doi: 10.1002/cpt.2572. Epub 2022 Mar 24. Clin Pharmacol Ther. 2023. PMID: 35253213 No abstract available.

10

Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.

Fletcher EP, Sahre M, Hon YY, Balakrishnan A, Zhou L, Sun Q, Wang J, Maxfield K, Naik R, Huang SM, Wang YC. Fletcher EP, et al. Among authors: maxfield k. AAPS J. 2023 May 26;25(4):54. doi: 10.1208/s12248-023-00819-0. AAPS J. 2023. PMID: 37231199 Review.

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