Search Results - "GOBBURU, Joga"

Clinical pharmacology review of escitalopram for the treatment of depression by Pastoor, Devin, Gobburu, Joga

“…Depression is a serious and debilitating psychiatric condition with serious societal health and economic implications. Escitalopram , the S-enantiomer of…”
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A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies by Johnson-Williams, Bernadette, Reynolds, Kellie, Gobburu, Joga, Rundio, Albert

“…Competency-based education has been commonly used to enhance the healthcare workforce for some time. A translational discipline that is integral to drug…”
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Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate by BRAVE, Michael, GOODMAN, Vicki, MEN, Angela, NOORY, Carol, RAMCHANDANI, Roshni, KENNA, Leslie, BOOTH, Brian, GOBBURU, Joga, XIAOPING JIANG, SRIDHARA, Rajeshwari, JUSTICE, Robert, PAZDUR, Richard, KAMINSKAS, Edvardas, FARRELL, Ann, TIMMER, William, POPE, Sarah, HARAPANHALLI, Ravi, SABER, Haleh, MORSE, David, BULLOCK, Julie

“…Purpose: On June 28, 2006, the U.S. Food and Drug Administration approved dasatinib (Sprycel; Bristol-Myers Squibb), a new small-molecule inhibitor of multiple…”
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Exposure-Response Analysis of Alvocidib (Flavopiridol) Treatment by Bolus or Hybrid Administration in Newly Diagnosed or Relapsed/Refractory Acute Leukemia Patients by LaCerte, Carl, Ivaturi, Vijay, Gobburu, Joga, Greer, Jacqueline M, Doyle, L Austin, Wright, John J, Karp, Judith E, Rudek, Michelle A

“…To elucidate any differences in the exposure-response of alvocidib (flavopiridol) given by 1-hour bolus or a hybrid schedule (30-minute bolus followed by a…”
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Correction to: Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus®) and Lantus® in healthy subjects: a double-blind, randomized clamp study by Bhatia, Ashima, Tawade, Shraddha, Mastim, Mushtaque, Kitabi, Eliford Ngaimisi, Gopalakrishnan, Mathangi, Shah, Manish, Yeshamaina, Sridhar, Gobburu, Joga, Sahib, Maharaj, Thakur, Dipak, Prasanna Kumar, K. M.

“…Authors would like to correct the error in table 2 of the online published article…”
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Abstract 12412: In Silico Evaluation of Dosing Regimens to Accommodate Coadministration of Mavacamten With Strong Inhibitors of Cytochrome P450 3A4 and Moderate Inhibitors of Cytochrome P450 2C19 in Patients With Obstructive Hypertrophic Cardiomyopathy by Merali, Samira, Bunn, Haden, Sychterz, Caroline, Chiang, Manting, puli, Shilpa, Sehnert, Amy J, Murthy, Bindu, Gobburu, Joga

“…Abstract only Background: Mavacamten is primarily metabolized by cytochrome P450 enzymes CYP2C19 and CYP3A4 and coadministration with strong CYP3A4 or moderate…”
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Pharmacodynamic Exposure-Response Analysis of Fracture Count Data Following Treatment with Burosumab in Patients with XLH by Mehta, Krina, Storopoli, Jose, Ramwani, Nikita, Quattrocchi, Emilia, Gobburu, Joga, Weber, Thomas, Hruska, Matthew W, Marsteller, Douglas

“…X-linked hypophosphatemia (XLH) is a rare genetic disorder caused by excessive fibroblast growth factor 23 (FGF23), leading to low serum phosphate levels…”
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Guiding Dyslipidemia Treatment: A Population Pharmacokinetic–Pharmacodynamic Framework for Obicetrapib by Dunn, Allison, Ditmarsch, Marc, Kastelein, John J. P., Kling, Douglas, Neild, Annie, Davidson, Michael H., Gobburu, Joga

“…Obicetrapib is a selective inhibitor of cholesteryl ester transfer protein that is currently in phase 3 of development for the treatment of dyslipidemia as…”
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Urine Osmolality Is a Potential Marker of Longer-Term Efficacy of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis by Ivaturi, Vijay, Gobburu, Joga, Leslie, Bruce, Wang, Xiaofeng, Jadhav, Pravin

“…Key Points Post hoc analyses of the TEMPO 3:4 trial suggest that short-term reductions in urine osmolality with tolvaptan predict effects on total kidney…”
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Urine Osmolality Is a Potential Marker of Longer-term Efficacy of Tolvaptan in ADPKD: A Post-hoc Analysis by Ivaturi, Vijay, Gobburu, Joga, Leslie, Bruce, Wang, Xiaofeng, Jadhav, Pravin

“…Total kidney volume (TKV) and estimated glomerular filtration rate (eGFR) are measures of progression and treatment response in autosomal dominant polycystic…”
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Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods by Sahre, Martina D., Guinn, Daphne, Ramamoorthy, Anuradha, Kim, Insook, Zhang, Xinyuan, Mehta, Ruby, Seo, Shirley, Mehta, Mehul, Gobburu, Joga, Madabushi, Rajanikanth

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Levonorgestrel release rates over 5 years with the Liletta® 52-mg intrauterine system by Creinin, Mitchell D, Jansen, Rolf, Starr, Robert M, Gobburu, Joga, Gopalakrishnan, Mathangi, Olariu, Andrea

“…Abstract Objective To understand the potential duration of action for Liletta®, we conducted this study to estimate levonorgestrel (LNG) release rates over…”
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Comparing Effects of Tolvaptan and Instruction to Increase Water Consumption in ADPKD: Post Hoc Analysis of TEMPO 3:4 by Gobburu, Joga, Ivaturi, Vijay, Wang, Xiaofeng, Shoaf, Susan E, Jadhav, Pravin, Perrone, Ronald D

“…Key Points In a post hoc analysis, short-term reduction in spot urine osmolality (Uosm) was associated with decreased kidney volume growth in autosomal…”
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Levonorgestrel Release Rates With LNG20, a New Levonorgestrel Intrauterine System [186] by Gopalakrishnan, Mathangi, Liu, Tao, Gobburu, Joga, Creinin, Mitchell David

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Quantitation of Cabozantinib in Human Plasma by LC–MS/MS by Jones, Reyna, Holleran, Julianne, Parise, Robert A, Rudek, Michelle A, Chan, Jennifer, Wen, Yujia, Gobburu, Joga, Lewis, Lionel D, Beumer, Jan H

“…Abstract To support a phase III randomized trial of the multi-targeted tyrosine kinase inhibitor cabozantinib in neuroendocrine tumors, we developed a…”
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A Model‐Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk by Sannala, Chenna Keshava Reddy, MacLean, Carol, Larsen, Finn, Os, Steve, Jadhav, Pravin, Shore, Neal, Morgans, Alicia K., Okwuosa, Tochukwu, Gobburu, Joga

“…Teverelix drug product (DP) is a parenteral gonadotropin‐releasing hormone (GnRH) antagonist that has been successfully tested in phase 2 trials for…”
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Abstract CT101: A model-based exposure-response (E-R) assessment of a nivolumab (NIVO) 4-weekly (Q4W) dosing schedule across multiple tumor types by Zhao, Xiaochen, Ivaturi, Vijay, Gopalakrishnan, Mathangi, Shen, Jun, Feng, Yan, Statkevich, Paul, Richards, Eric, Rashford, Michelle, Goodman, Vicki, Gobburu, Joga, Bello, Akintunde, Roy, Amit, Agrawal, Shruti

“…Abstract Introduction: The anti-PD-1 checkpoint inhibitor NIVO provides favorable safety and efficacy when administered at 3 mg/kg Q2W across multiple tumor…”
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Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus®) and Lantus® in healthy subjects: a double-blind, randomized clamp study by Bhatia, Ashima, Tawade, Shraddha, Mastim, Mushtaque, Kitabi, Eliford Ngaimisi, Gopalakrishnan, Mathangi, Shah, Manish, Yeshamaina, Sridhar, Gobburu, Joga, Sahib, Maharaj, Thakur, Dipak, Prasanna Kumar, K. M.

“…Aims The objective of the study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus ®…”
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A Phase 1 Randomized Dose-Escalation Study of a Human Monoclonal Antibody to IL-6 in CKD by Nowak, Kristen L, Kakkar, Rahul, Devalaraja, Matt, Lo, Larry, Park, Wansu, Gobburu, Joga, Kling, Douglas, Davidson, Michael, Chonchol, Michel

“…Chronic systemic inflammation is highly prevalent in patients with CKD (measured as an elevated high-sensitivity C-reactive protein, hsCRP) and independently…”
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Phase I and pharmacokinetic trial of the antitemolerase agent KML001 (KML) and cisplatin (CDDP) in advanced solid tumors by Edelman, Martin J., Feliciano, Josephine Louella, Styblo, Miroslav, Liu, Tao, Lapidus, Rena G., Saunders, Jesse, Gobburu, Joga

“…Abstract only 2515 Background: Telomerase is overexpressed in most solid tumors and rarely expressed in adult tissues and is therefore a promising target. We…”
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