Earp JC - Search Results

1

Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective.

Pan X, Wang L, Liu J, Earp JC, Yang Y, Yu J, Li F, Bi Y, Bhattaram A, Zhu H. Pan X, et al. Among authors: earp jc. J Clin Pharmacol. 2023 Nov;63 Suppl 2:S65-S77. doi: 10.1002/jcph.2349. J Clin Pharmacol. 2023. PMID: 37942906 Review.

2

Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA.

Penzenstadler J, Earp JC, Wood Heickman LK, Pluchino K. Penzenstadler J, et al. Among authors: earp jc. Diabetologia. 2023 Mar;66(3):603-604. doi: 10.1007/s00125-022-05853-9. Epub 2022 Dec 21. Diabetologia. 2023. PMID: 36542112 No abstract available.

3

Biparatopic sybodies neutralize SARS-CoV-2 variants of concern and mitigate drug resistance.

Walter JD, Scherer M, Hutter CAJ, Garaeva AA, Zimmermann I, Wyss M, Rheinberger J, Ruedin Y, Earp JC, Egloff P, Sorgenfrei M, Hürlimann LM, Gonda I, Meier G, Remm S, Thavarasah S, van Geest G, Bruggmann R, Zimmer G, Slotboom DJ, Paulino C, Plattet P, Seeger MA. Walter JD, et al. Among authors: earp jc. EMBO Rep. 2022 Apr 5;23(4):e54199. doi: 10.15252/embr.202154199. Epub 2022 Mar 7. EMBO Rep. 2022. PMID: 35253970 Free PMC article.

4

Reply to White et al.

Kitabi E, Bensman TJ, Earp JC, Chilukuri DM, Smith H, Ball L, O'Shaughnessy E, Yasinskaya Y, Reynolds KS. Kitabi E, et al. Among authors: earp jc. Clin Infect Dis. 2022 Aug 25;75(2):359. doi: 10.1093/cid/ciac025. Clin Infect Dis. 2022. PMID: 35023546 No abstract available.

5

Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic.

Xiong Y, Fan J, Kitabi E, Zhang X, Bi Y, Grimstein M, Yang Y, Earp JC, Zheng N, Liu J, Wang Y, Zhu H. Xiong Y, et al. Among authors: earp jc. Clin Pharmacol Ther. 2022 Mar;111(3):572-578. doi: 10.1002/cpt.2491. Epub 2021 Dec 4. Clin Pharmacol Ther. 2022. PMID: 34807992 Free PMC article. Review.

6

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.

Bai JPF, Earp JC, Florian J, Madabushi R, Strauss DG, Wang Y, Zhu H. Bai JPF, et al. Among authors: earp jc. CPT Pharmacometrics Syst Pharmacol. 2021 Dec;10(12):1479-1484. doi: 10.1002/psp4.12709. Epub 2021 Nov 3. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34734497 Free PMC article.

7

Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction.

Fan J, Yang Y, Grimstein M, Zhang X, Kitabi E, Earp JC, Arya V, Reynolds KS, Zhu H, Wang Y. Fan J, et al. Among authors: earp jc. Clin Pharmacol Ther. 2022 Mar;111(3):624-634. doi: 10.1002/cpt.2445. Epub 2021 Nov 8. Clin Pharmacol Ther. 2022. PMID: 34656075

8

Critical discussion on drug efflux in Mycobacterium tuberculosis.

Remm S, Earp JC, Dick T, Dartois V, Seeger MA. Remm S, et al. Among authors: earp jc. FEMS Microbiol Rev. 2022 Feb 9;46(1):fuab050. doi: 10.1093/femsre/fuab050. FEMS Microbiol Rev. 2022. PMID: 34637511 Free PMC article. Review.

9

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.

Bai JPF, Schmidt BJ, Gadkar KG, Damian V, Earp JC, Friedrich C, van der Graaf PH, Madabushi R, Musante CJ, Naik K, Rogge M, Zhu H. Bai JPF, et al. Among authors: earp jc. AAPS J. 2021 Apr 30;23(3):60. doi: 10.1208/s12248-021-00585-x. AAPS J. 2021. PMID: 33931790

10

Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria.

Kitabi E, Bensman TJ, Earp JC, Chilukuri DM, Smith H, Ball L, O'Shaughnessy E, Yasinskaya Y, Colangelo PM, Reynolds KS. Kitabi E, et al. Among authors: earp jc. Clin Infect Dis. 2021 Sep 7;73(5):903-906. doi: 10.1093/cid/ciab149. Clin Infect Dis. 2021. PMID: 33605994

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