Budha N - Search Results

1

A PK/PD Analysis of Circulating Biomarkers and Their Relationship to Tumor Response in Atezolizumab-Treated non-small Cell Lung Cancer Patients.

Netterberg I, Li CC, Molinero L, Budha N, Sukumaran S, Stroh M, Jonsson EN, Friberg LE. Netterberg I, et al. Among authors: budha n. Clin Pharmacol Ther. 2019 Feb;105(2):486-495. doi: 10.1002/cpt.1198. Epub 2018 Sep 4. Clin Pharmacol Ther. 2019. PMID: 30058723 Free PMC article. Clinical Trial.

2

Drug absorption interactions between oral targeted anticancer agents and PPIs: is pH-dependent solubility the Achilles heel of targeted therapy?

Budha NR, Frymoyer A, Smelick GS, Jin JY, Yago MR, Dresser MJ, Holden SN, Benet LZ, Ware JA. Budha NR, et al. Clin Pharmacol Ther. 2012 Aug;92(2):203-13. doi: 10.1038/clpt.2012.73. Epub 2012 Jun 27. Clin Pharmacol Ther. 2012. PMID: 22739140 Review.

3

Impact of physiologically based pharmacokinetic models on regulatory reviews and product labels: Frequent utilization in the field of oncology.

Yoshida K, Budha N, Jin JY. Yoshida K, et al. Among authors: budha n. Clin Pharmacol Ther. 2017 May;101(5):597-602. doi: 10.1002/cpt.622. Epub 2017 Mar 15. Clin Pharmacol Ther. 2017. PMID: 28074611 Free PMC article. Review.

4

A phase 1 study to evaluate the safety and LDL cholesterol-lowering effects of RG7652, a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9.

Baruch A, Luca D, Kahn RS, Cowan KJ, Leabman M, Budha NR, Chiu CPC, Wu Y, Kirchhofer D, Peterson A, Davis JC Jr, Tingley WG. Baruch A, et al. Clin Cardiol. 2017 Jul;40(7):503-511. doi: 10.1002/clc.22687. Epub 2017 Mar 22. Clin Cardiol. 2017. PMID: 28326559 Free PMC article. Clinical Trial.

5

Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.

Galluppi GR, Ahamadi M, Bhattacharya S, Budha N, Gheyas F, Li CC, Chen Y, Dosne AG, Kristensen NR, Magee M, Samtani MN, Sinha V, Taskar K, Upreti VV, Yang J, Cook J. Galluppi GR, et al. Among authors: budha n. Clin Pharmacol Ther. 2024 Mar 22. doi: 10.1002/cpt.3245. Online ahead of print. Clin Pharmacol Ther. 2024. PMID: 38519861 Review.

6

Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study.

Peng K, Xu K, Liu L, Hendricks R, Delarosa R, Erickson R, Budha N, Leabman M, Song A, Kaur S, Fischer SK. Peng K, et al. Among authors: budha n. MAbs. 2014;6(6):1500-8. doi: 10.4161/mabs.36208. MAbs. 2014. PMID: 25484037 Free PMC article. Clinical Trial.

7

Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9.

Budha NR, Leabman M, Jin JY, Wada DR, Baruch A, Peng K, Tingley WG, Davis JD. Budha NR, et al. AAPS J. 2015 Jul;17(4):881-90. doi: 10.1208/s12248-015-9750-8. Epub 2015 Mar 31. AAPS J. 2015. PMID: 25823668 Free PMC article. Clinical Trial.

8

Population pharmacokinetics and dosing implications for cobimetinib in patients with solid tumors.

Han K, Jin JY, Marchand M, Eppler S, Choong N, Hack SP, Tikoo N, Bruno R, Dresser M, Musib L, Budha NR. Han K, et al. Among authors: budha nr. Cancer Chemother Pharmacol. 2015 Nov;76(5):917-24. doi: 10.1007/s00280-015-2862-0. Epub 2015 Sep 13. Cancer Chemother Pharmacol. 2015. PMID: 26365290

9

A Phase I Dose-Escalation Study Evaluating the Safety Tolerability and Pharmacokinetics of CUDC-427, a Potent, Oral, Monovalent IAP Antagonist, in Patients with Refractory Solid Tumors.

Tolcher AW, Bendell JC, Papadopoulos KP, Burris HA, Patnaik A, Fairbrother WJ, Wong H, Budha N, Darbonne WC, Peale F, Mamounas M, Royer-Joo S, Yu R, Portera CC, Infante JR. Tolcher AW, et al. Among authors: budha n. Clin Cancer Res. 2016 Sep 15;22(18):4567-73. doi: 10.1158/1078-0432.CCR-16-0308. Epub 2016 Apr 13. Clin Cancer Res. 2016. PMID: 27076626 Clinical Trial.

10

Population repeated time-to-event analysis of exacerbations in asthma patients: A novel approach for predicting asthma exacerbations based on biomarkers, spirometry, and diaries/questionnaires.

Svensson RJ, Ribbing J, Kotani N, Dolton M, Vadhavkar S, Cheung D, Staton T, Choy DF, Putnam W, Jin J, Budha N, Karlsson MO, Quartino A, Zhu R. Svensson RJ, et al. Among authors: budha n. CPT Pharmacometrics Syst Pharmacol. 2021 Oct;10(10):1221-1235. doi: 10.1002/psp4.12690. Epub 2021 Aug 5. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34346168 Free PMC article. Clinical Trial.

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