Search Results - "VISHWANATHAN, Karthick"

Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies by Planchard, David, Brown, Kathryn H., Kim, Dong-Wan, Kim, Sang-We, Ohe, Yuichiro, Felip, Enriqueta, Leese, Philip, Cantarini, Mireille, Vishwanathan, Karthick, Jänne, Pasi A., Ranson, Malcolm, Dickinson, Paul A.

“…Purpose Osimertinib (AZD9291) 80 mg once daily is approved by the US FDA for the treatment of patients with metastatic EGFR T790M-positive NSCLC whose disease…”
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Development, Verification, and Prediction of Osimertinib Drug–Drug Interactions Using PBPK Modeling Approach to Inform Drug Label by Pilla Reddy, Venkatesh, Walker, Michael, Sharma, Pradeep, Ballard, Peter, Vishwanathan, Karthick

“…Osimertinib is a potent, highly selective, irreversible inhibitor of epidermal growth factor receptor (EGFR) and T790M resistance mutation. In vitro metabolism…”
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Population pharmacokinetics and exposure–response of selumetinib and its N‐desmethyl metabolite in pediatric patients with neurofibromatosis type 1 and inoperable plexiform neurofibromas by Schalkwijk, Stein, Zhou, Li, Cohen‐Rabbie, Sarit, Jain, Lokesh, Freshwater, Tomoko, So, Karen, He, Zhongqing, Gioni, Ioanna, Tomkinson, Helen, Vishwanathan, Karthick, Zhou, Diansong

“…Purpose Selumetinib (ARRY-142886) is a potent, selective, MEK1/2 inhibitor approved in the US for the treatment of children (≥ 2 years) with neurofibromatosis…”
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The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib by Vishwanathan, Karthick, Dickinson, Paul A., So, Karen, Thomas, Karen, Chen, Yuh‐Min, De Castro Carpeño, Javier, Dingemans, Anne‐Marie C., Kim, Hye Ryun, Kim, Joo‐Hang, Krebs, Matthew G., Chih‐Hsin Yang, James, Bui, Khanh, Weilert, Doris, Harvey, R. Donald

“…Aims We investigated the effects of a strong CYP3A4 inhibitor (itraconazole) or inducer (rifampicin) on the pharmacokinetics of the epidermal growth factor…”
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Managing the Risk of CYP3A Induction in Drug Development: A Strategic Approach by Jones, Barry C, Rollison, Helen, Johansson, Susanne, Kanebratt, Kajsa P, Lambert, Craig, Vishwanathan, Karthick, Andersson, Tommy B

“…Induction of cytochrome P450 (P450) can impact the efficacy and safety of drug molecules upon multiple dosing with coadministered drugs. This strategy is…”
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Mechanistic physiology-based pharmacokinetic modeling to elucidate vincristine-induced peripheral neuropathy following treatment with novel kinase inhibitors by Pilla Reddy, Venkatesh, Fretland, Adrian J., Zhou, Diansong, Sharma, Shringi, Chen, Buyun, Vishwanathan, Karthick, McGinnity, Dermot F., Xu, Yan, Ware, Joseph A.

“…Purpose Limited information is available regarding the drug–drug interaction (DDI) potential of molecular targeted agents and rituximab plus cyclophosphamide,…”
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Effect of multiple‐dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin by Harvey, R. Donald, Aransay, Noemi Reguart, Isambert, Nicolas, Lee, Jong‐Seok, Arkenau, Tobias, Vansteenkiste, Johan, Dickinson, Paul A., Bui, Khanh, Weilert, Doris, So, Karen, Thomas, Karen, Vishwanathan, Karthick

“…Aim We report on two Phase 1, open‐label, single‐arm studies assessing the effect of osimertinib on simvastatin (CYP3A substrate) and rosuvastatin (breast…”
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Absolute Bioavailability of Osimertinib in Healthy Adults by Vishwanathan, Karthick, So, Karen, Thomas, Karen, Bramley, Alex, English, Stephen, Collier, Jo

“…Osimertinib is a third‐generation, central nervous system–active, epidermal growth factor receptor–tyrosine kinase inhibitor (EGFR‐TKI) selective for EGFR‐TKI…”
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A mechanistic PK/PD model of AZD0171 (anti‐LIF) to support Phase II dose selection by Shahraz, Azar, Penney, Mark, Candido, Juliana, Opoku‐Ansah, Grace, Neubauer, Melanie, Eyles, Jim, Ojo, Oluwaseun, Liu, Nelson, Luheshi, Nadia M., Phipps, Alex, Vishwanathan, Karthick

“…AZD0171 (INN: Falbikitug) is being developed as a humanized monoclonal antibody (mAb), immunoglobulin G subclass 1 (IgG1), which binds specifically to the…”
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Evaluation of the Drug–Drug Interaction Potential of Acalabrutinib and Its Active Metabolite, ACP‐5862, Using a Physiologically‐Based Pharmacokinetic Modeling Approach by Zhou, Diansong, Podoll, Terry, Xu, Yan, Moorthy, Ganesh, Vishwanathan, Karthick, Ware, Joseph, Slatter, J. Greg, Al‐Huniti, Nidal

“…Acalabrutinib, a selective, covalent Bruton tyrosine kinase inhibitor, is a CYP3A substrate and weak CYP3A/CYP2C8 inhibitor. A physiologically‐based…”
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The metabotropic glutamate receptor 7 allosteric modulator AMN082: a monoaminergic agent in disguise? by Sukoff Rizzo, Stacey J, Leonard, Sarah K, Gilbert, Adam, Dollings, Paul, Smith, Deborah L, Zhang, Mei-Yi, Di, Li, Platt, Brian J, Neal, Sarah, Dwyer, Jason M, Bender, Corey N, Zhang, Jean, Lock, Tim, Kowal, Dianne, Kramer, Angela, Randall, Andrew, Huselton, Christine, Vishwanathan, Karthick, Tse, Susanna Y, Butera, John, Ring, Robert H, Rosenzweig-Lipson, Sharon, Hughes, Zoë A, Dunlop, John

“…Metabotropic glutamate receptor 7 (mGluR7) remains the most elusive of the eight known mGluRs primarily because of the limited availability of tool compounds…”
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Brain exposure of osimertinib in patients with epidermal growth factor receptor mutation non‐small cell lung cancer and brain metastases: A positron emission tomography and magnetic resonance imaging study by Ekman, Simon, Cselényi, Zsolt, Varrone, Andrea, Jucaite, Aurelija, Martin, Heather, Schou, Magnus, Johnström, Peter, Laus, Gianluca, Lewensohn, Rolf, Brown, Andrew P., Aart, Jasper, Vishwanathan, Karthick, Farde, Lars

“…Brain metastases (BMs) are associated with poor prognosis in epidermal growth factor receptor mutation‐positive (EGFRm) non‐small cell lung cancer (NSCLC)…”
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Impact of Disease and Treatment Response in Drug–Drug Interaction Studies: Osimertinib and Simvastatin in Advanced Non‐Small Cell Lung Cancer by Vishwanathan, Karthick, Cantarini, Mireille, So, Karen, Masson, Eric, Fetterolf, Jennifer, Ramalingam, Suresh S., Harvey, R. Donald

“…A phase I, open‐label study (NCT02197234) assessed the effects of osimertinib on simvastatin exposure in patients with advanced epidermal growth factor…”
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A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment by Vishwanathan, Karthick, Sanchez‐Simon, Inmaculada, Keam, Bhumsuk, Penel, Nicolas, Miguel‐Luken, Maria, Weilert, Doris, Mills, Andrew, Marotti, Marcelo, Johnson, Martin, Ravaud, Alain

“…Osimertinib is a third‐generation, irreversible, oral epidermal growth factor receptor (EGFR)‐tyrosine kinase inhibitor (TKI) that potently and selectively…”
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Determination of arginine and methylated arginines in human plasma by liquid chromatography–tandem mass spectrometry by Vishwanathan, Karthick, Tackett, Randall L, Stewart, James T, Bartlett, Michael G

“…Nitric oxide (NO) is synthesized from l-arginine (ARG) catalyzed by the enzyme nitric oxide synthase (NOS) and is important in the regulation of vascular tone,…”
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Determination of moxifloxacin in human plasma by liquid chromatography electrospray ionization tandem mass spectrometry by Vishwanathan, Karthick, Bartlett, Michael G, Stewart, James T

“…Moxifloxacin is an advanced-generation, 8-methoxy fluoroquinolone that is active against a broad spectrum of pathogens, including antibiotic resistant…”
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Determination of gatifloxacin in human plasma by liquid chromatography/electrospray tandem mass spectrometry by Vishwanathan, Karthick, Bartlett, Michael G., Stewart, James T.

“…Gatifloxacin is an advanced‐generation, 8‐methoxyfluoroquinolone that is active against a broad spectrum of pathogens, including antiobiotic resistant…”
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Assessing Trends in Cytokine–CYP Drug Interactions and Relevance to Drug Dosing by Sawant-Basak, Aarti, Olabode, Damilola, Dai, David, Vishwanathan, Karthick, Phipps, Alex

“…The regulation of drug-metabolizing enzymes and transporters by cytokines has been extensively studied in vitro and in clinic. Cytokine-mediated suppression of…”
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Osimertinib in Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer and Leptomeningeal Metastases: The BLOOM Study by Yang, James C H, Kim, Sang-We, Kim, Dong-Wan, Lee, Jong-Seok, Cho, Byoung Chul, Ahn, Jin-Seok, Lee, Dae H, Kim, Tae Min, Goldman, Jonathan W, Natale, Ronald B, Brown, Andrew P, Collins, Barbara, Chmielecki, Juliann, Vishwanathan, Karthick, Mendoza-Naranjo, Ariadna, Ahn, Myung-Ju

“…In this phase I study (BLOOM), osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), was evaluated in…”
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Population pharmacokinetics and exposure‐response of osimertinib in patients with non‐small cell lung cancer by Brown, Kathryn, Comisar, Craig, Witjes, Han, Maringwa, John, Greef, Rik, Vishwanathan, Karthick, Cantarini, Mireille, Cox, Eugène

“…Aims To develop a population (pop) pharmacokinetic (PK) model for osimertinib (AZD9291) and its metabolite (AZ5104) and investigate the exposure–response…”
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