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A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment.
Published in:
Pharmacology Research & Perspectives, 2020, v. 8, n. 4, p. 1, doi. 10.1002/prp2.613
By:
- Vishwanathan, Karthick;
- Sanchez-Simon, Inmaculada;
- Bhumsuk Keam;
- Penel, Nicolas;
- de Miguel-Luken, Maria;
- Weilert, Doris;
- Mills, Andrew;
- Marotti, Marcelo;
- Johnson, Martin;
- Ravaud, Alain
Publication type:
Article
Absolute Bioavailability of Osimertinib in Healthy Adults.
Published in:
Clinical Pharmacology in Drug Development, 2019, v. 8, n. 2, p. 198, doi. 10.1002/cpdd.467
By:
- Vishwanathan, Karthick;
- So, Karen;
- Thomas, Karen;
- Bramley, Alex;
- English, Stephen;
- Collier, Jo
Publication type:
Article
A Phase 1 Study to Evaluate Absolute Bioavailability and Absorption, Distribution, Metabolism, and Excretion of Savolitinib in Healthy Male Volunteers.
Published in:
Clinical Pharmacology in Drug Development, 2023, v. 12, n. 4, p. 424, doi. 10.1002/cpdd.1224
By:
- Miah, Kowser;
- Vishwanathan, Karthick;
- Scarfe, Graeme;
- Li, Yan;
- Hara, Indira;
- Cantarini, Mireille;
- Argue, John;
- Menakuru, Somasekhar R.
Publication type:
Article
Corrigendum: Responding to the challenge of untreatable gonorrhea: ETX0914, a first-in-class agent with a distinct mechanism-of-action against bacterial Type II topoisomerases.
Published in:
Scientific Reports, 2015, p. 14157, doi. 10.1038/srep14157
By:
- Basarab, Gregory S.;
- Kern, Gunther H.;
- McNulty, John;
- Mueller, John P.;
- Lawrence, Kenneth;
- Vishwanathan, Karthick;
- Alm, Richard A.;
- Barvian, Kevin;
- Doig, Peter;
- Galullo, Vincent;
- Gardner, Humphrey;
- Gowravaram, Madhusudhan;
- Huband, Michael;
- Kimzey, Amy;
- Morningstar, Marshall;
- Kutschke, Amy;
- Lahiri, Sushmita D.;
- Perros, Manos;
- Singh, Renu;
- Schuck, Virna J. A.
Publication type:
Article
Acalabrutinib CYP3A‐mediated drug–drug interactions: Clinical evaluations and physiologically based pharmacokinetic modelling to inform dose adjustment strategy.
Published in:
British Journal of Clinical Pharmacology, 2022, v. 88, n. 8, p. 3716, doi. 10.1111/bcp.15278
By:
- Chen, Buyun;
- Zhou, Diansong;
- Wei, Hua;
- Yotvat, Marmor;
- Zhou, Li;
- Cheung, Jean;
- Sarvaria, Nicole;
- Lai, Richard;
- Sharma, Shringi;
- Vishwanathan, Karthick;
- Ware, Joseph
Publication type:
Article
Exposure–response analysis of acalabrutinib and its active metabolite, ACP‐5862, in patients with B‐cell malignancies.
Published in:
British Journal of Clinical Pharmacology, 2022, v. 88, n. 5, p. 2284, doi. 10.1111/bcp.15087
By:
- Edlund, Helena;
- Buil‐Bruna, Núria;
- Vishwanathan, Karthick;
- Wei, Helen;
- Raman, Rakesh;
- de Kock, Miné;
- He, Zhongqing;
- Liu, Huan;
- Baek, Marshall;
- Ware, Joseph;
- Patel, Priti;
- Tomkinson, Helen;
- Sharma, Shringi
Publication type:
Article
Clinical evaluation of the potential drug–drug interactions of savolitinib: Interaction with rifampicin, itraconazole, famotidine or midazolam.
Published in:
British Journal of Clinical Pharmacology, 2022, v. 88, n. 2, p. 655, doi. 10.1111/bcp.14994
By:
- Ren, Song;
- Vishwanathan, Karthick;
- Cantarini, Mireille;
- Frewer, Paul;
- Hara, Indira;
- Scarfe, Graeme;
- Burke, Wendy;
- Schalkwijk, Stein;
- Li, Yan;
- Han, David;
- Goldwater, Ronald
Publication type:
Article
Improved characterization of the pharmacokinetics of acalabrutinib and its pharmacologically active metabolite, ACP‐5862, in patients with B‐cell malignancies and in healthy subjects using a population pharmacokinetic approach.
Published in:
British Journal of Clinical Pharmacology, 2022, v. 88, n. 2, p. 846, doi. 10.1111/bcp.14988
By:
- Edlund, Helena;
- Bellanti, Francesco;
- Liu, Huan;
- Vishwanathan, Karthick;
- Tomkinson, Helen;
- Ware, Joseph;
- Sharma, Shringi;
- Buil‐Bruna, Núria
Publication type:
Article
Effect of multiple‐dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin.
Published in:
British Journal of Clinical Pharmacology, 2018, v. 84, n. 12, p. 2877, doi. 10.1111/bcp.13753
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
Publication type:
Article
The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib.
Published in:
British Journal of Clinical Pharmacology, 2018, v. 84, n. 6, p. 1156, doi. 10.1111/bcp.13534
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
Publication type:
Article
Population pharmacokinetics and exposure-response of osimertinib in patients with non-small cell lung cancer.
Published in:
British Journal of Clinical Pharmacology, 2017, v. 83, n. 6, p. 1216, doi. 10.1111/bcp.13223
By:
- Brown, Kathryn;
- Comisar, Craig;
- Witjes, Han;
- Maringwa, John;
- Greef, Rik;
- Vishwanathan, Karthick;
- Cantarini, Mireille;
- Cox, Eugène
Publication type:
Article
A PET study in healthy subjects of brain exposure of 11 C-labelled osimertinib – A drug intended for treatment of brain metastases in non-small cell lung cancer.
Published in:
Journal of Cerebral Blood Flow & Metabolism, 2020, v. 40, n. 4, p. 799, doi. 10.1177/0271678X19843776
By:
- Varrone, Andrea;
- Varnäs, Katarina;
- Jucaite, Aurelija;
- Cselényi, Zsolt;
- Johnström, Peter;
- Schou, Magnus;
- Vazquez-Romero, Ana;
- Moein, Mohammad M;
- Halldin, Christer;
- Brown, Andrew P;
- Vishwanathan, Karthick;
- Farde, Lars
Publication type:
Article
Determination of gatifloxacin in human plasma by liquid chromatography/electrospray tandem mass spectrometry.
Published in:
Rapid Communications in Mass Spectrometry: RCM, 2001, v. 15, n. 12, p. 915, doi. 10.1002/rcm.322
By:
- Vishwanathan, Karthick;
- Bartlett, Michael G.;
- Stewart, James T.
Publication type:
Article
Determination of antimigraine compounds rizatriptan, zolmitriptan, naratriptan and sumatriptan in human serum by liquid chromatography/electrospray tandem mass spectrometry.
Published in:
Rapid Communications in Mass Spectrometry: RCM, 2000, v. 14, n. 3, p. 168, doi. 10.1002/(SICI)1097-0231(20000215)14:3<168::AID-RCM861>3.0.CO;2-9
By:
- Vishwanathan, Karthick;
- Bartlett, Michael G.;
- Stewart, James T.
Publication type:
Article
Phase I studies of AZD1208, a proviral integration Moloney virus kinase inhibitor in solid and haematological cancers.
Published in:
2018
By:
- Cortes, Jorge;
- Tamura, Kenji;
- DeAngelo, Daniel J.;
- de Bono, Johann;
- Lorente, David;
- Minden, Mark;
- Uy, Geoffrey L.;
- Kantarjian, Hagop;
- Chen, Lisa S.;
- Gandhi, Varsha;
- Godin, Robert;
- Keating, Karen;
- McEachern, Kristen;
- Vishwanathan, Karthick;
- Pease, Janet Elizabeth;
- Dean, Emma
Publication type:
journal article
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 2, p. 349, doi. 10.1002/cpt.3113
By:
- Johnson, Martin;
- Serra Traynor, Carlos;
- Vishwanathan, Karthick;
- Overend, Philip;
- Hartmaier, Ryan;
- Markovets, Aleksandra;
- Chmielecki, Juliann;
- Mugundu, Ganesh M.;
- Barrett, J. Carl;
- Tomkinson, Helen;
- Ramalingam, Suresh S.
Publication type:
Article
Harnessing Meta‐analysis to Refine an Oncology Patient Population for Physiology‐Based Pharmacokinetic Modeling of Drugs.
Published in:
Clinical Pharmacology & Therapeutics, 2018, v. 103, n. 2, p. 271, doi. 10.1002/cpt.917
By:
- Schwenger, Emily;
- Reddy, Venkatesh Pilla;
- Moorthy, Ganesh;
- Sharma, Pradeep;
- Tomkinson, Helen;
- Masson, Eric;
- Vishwanathan, Karthick
Publication type:
Article
Mechanistic physiology-based pharmacokinetic modeling to elucidate vincristine-induced peripheral neuropathy following treatment with novel kinase inhibitors.
Published in:
Cancer Chemotherapy & Pharmacology, 2021, v. 88, n. 3, p. 451, doi. 10.1007/s00280-021-04302-5
By:
- Pilla Reddy, Venkatesh;
- Fretland, Adrian J.;
- Zhou, Diansong;
- Sharma, Shringi;
- Chen, Buyun;
- Vishwanathan, Karthick;
- McGinnity, Dermot F.;
- Xu, Yan;
- Ware, Joseph A.
Publication type:
Article
Population pharmacokinetics and exposure–response of selumetinib and its N‐desmethyl metabolite in pediatric patients with neurofibromatosis type 1 and inoperable plexiform neurofibromas.
Published in:
Cancer Chemotherapy & Pharmacology, 2021, v. 88, n. 2, p. 189, doi. 10.1007/s00280-021-04274-6
By:
- Schalkwijk, Stein;
- Zhou, Li;
- Cohen‐Rabbie, Sarit;
- Jain, Lokesh;
- Freshwater, Tomoko;
- So, Karen;
- He, Zhongqing;
- Gioni, Ioanna;
- Tomkinson, Helen;
- Vishwanathan, Karthick;
- Zhou, Diansong
Publication type:
Article
Resistance models to EGFR inhibition and chemotherapy in non-small cell lung cancer via analysis of tumour size dynamics.
Published in:
2019
By:
- Mistry, Hitesh B.;
- Helmlinger, Gabriel;
- Al-Huniti, Nidal;
- Vishwanathan, Karthick;
- Yates, James
Publication type:
journal article
Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies.
Published in:
2016
By:
- Planchard, David;
- Brown, Kathryn;
- Kim, Dong-Wan;
- Kim, Sang-We;
- Ohe, Yuichiro;
- Felip, Enriqueta;
- Leese, Philip;
- Cantarini, Mireille;
- Vishwanathan, Karthick;
- Jänne, Pasi;
- Ranson, Malcolm;
- Dickinson, Paul;
- Brown, Kathryn H;
- Jänne, Pasi A;
- Dickinson, Paul A
Publication type:
journal article
A mechanistic PK/PD model of AZD0171 (anti‐LIF) to support Phase II dose selection.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2024, v. 13, n. 10, p. 1670, doi. 10.1002/psp4.13204
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
Publication type:
Article
Evaluation of the Drug–Drug Interaction Potential of Acalabrutinib and Its Active Metabolite, ACP‐5862, Using a Physiologically‐Based Pharmacokinetic Modeling Approach.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2019, v. 8, n. 7, p. 489, doi. 10.1002/psp4.12408
By:
- Zhou, Diansong;
- Podoll, Terry;
- Xu, Yan;
- Moorthy, Ganesh;
- Vishwanathan, Karthick;
- Ware, Joseph;
- Slatter, J. Greg;
- Al‐Huniti, Nidal
Publication type:
Article
Development, Verification, and Prediction of Osimertinib Drug–Drug Interactions Using PBPK Modeling Approach to Inform Drug Label.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2018, v. 7, n. 5, p. 321, doi. 10.1002/psp4.12289
By:
- Pilla Reddy, Venkatesh;
- Walker, Michael;
- Sharma, Pradeep;
- Ballard, Peter;
- Vishwanathan, Karthick
Publication type:
Article
Responding to the challenge of untreatable gonorrhea: ETX0914, a first-in-class agent with a distinct mechanism-of-action against bacterial Type II topoisomerases.
Published in:
Scientific Reports, 2015, p. 11827, doi. 10.1038/srep11827
By:
- Basarab, Gregory S.;
- Singh, Renu;
- Kern, Gunther H.;
- Vishwanathan, Karthick;
- Alm, Richard A.;
- Doig, Peter;
- Galullo, Vincent;
- Gardner, Humphrey;
- Kimzey, Amy;
- Kutschke, Amy;
- Lahiri, Sushmita D.;
- Walkup, Grant;
- Newman, Joseph V.;
- McNulty, John;
- Perros, Manos;
- Tommasi, Ruben;
- Mueller, John P.;
- Lawrence, Kenneth;
- Barvian, Kevin;
- Gowravaram, Madhusudhan
Publication type:
Article
Evaluation of the Pharmacokinetics and Safety of a Single Dose of Acalabrutinib in Subjects With Hepatic Impairment.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 6, p. 812, doi. 10.1002/jcph.2013
By:
- Xu, Yan;
- Izumi, Raquel;
- Nguyen, Helen;
- Kwan, Anna;
- Kuo, Howard;
- Madere, Jeannine;
- Slatter, J. Greg;
- Podoll, Terry;
- Vishwanathan, Karthick;
- Marbury, Thomas;
- Smith, William;
- Preston, Richard A.;
- Sharma, Shringi;
- Ware, Joseph A.
Publication type:
Article
Physiologically Based Pharmacokinetic Modeling for Selumetinib to Evaluate Drug‐Drug Interactions and Pediatric Dose Regimens.
Published in:
Journal of Clinical Pharmacology, 2021, v. 61, n. 11, p. 1493, doi. 10.1002/jcph.1935
By:
- Cohen‐Rabbie, Sarit;
- Zhou, Li;
- Vishwanathan, Karthick;
- Wild, Martin;
- Xu, Sherrie;
- Freshwater, Tomoko;
- Jain, Lokesh;
- Schalkwijk, Stein;
- Tomkinson, Helen;
- Zhou, Diansong
Publication type:
Article
Modulation of Fexofenadine Pharmacokinetics by Osimertinib in Patients With Advanced EGFR‐Mutated Non–Small Cell Lung Cancer.
Published in:
Journal of Clinical Pharmacology, 2019, v. 59, n. 8, p. 1099, doi. 10.1002/jcph.1403
By:
- Calvo, Emiliano;
- Lee, Jong‐Seok;
- Kim, Sang‐We;
- Moreno, Victor;
- Carpeno, Javier;
- Weilert, Doris;
- Laus, Gianluca;
- Mann, Helen;
- Vishwanathan, Karthick
Publication type:
Article
The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non‐Small‐Cell Lung Cancer and in Healthy Volunteers.
Published in:
Journal of Clinical Pharmacology, 2018, v. 58, n. 4, p. 474, doi. 10.1002/jcph.1035
By:
- Vishwanathan, Karthick;
- Dickinson, Paul A.;
- Bui, Khanh;
- Cassier, Philippe A.;
- Greystoke, Alastair;
- Lisbon, Eleanor;
- Moreno, Victor;
- So, Karen;
- Thomas, Karen;
- Weilert, Doris;
- Yap, Timothy A.;
- Plummer, Ruth
Publication type:
Article
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.
Published in:
CTS: Clinical & Translational Science, 2023, v. 16, n. 6, p. 955, doi. 10.1111/cts.13500
By:
- Ekman, Simon;
- Cselényi, Zsolt;
- Varrone, Andrea;
- Jucaite, Aurelija;
- Martin, Heather;
- Schou, Magnus;
- Johnström, Peter;
- Laus, Gianluca;
- Lewensohn, Rolf;
- Brown, Andrew P.;
- van der Aart, Jasper;
- Vishwanathan, Karthick;
- Farde, Lars
Publication type:
Article
Impact of Disease and Treatment Response in Drug–Drug Interaction Studies: Osimertinib and Simvastatin in Advanced Non‐Small Cell Lung Cancer.
Published in:
CTS: Clinical & Translational Science, 2020, v. 13, n. 1, p. 41, doi. 10.1111/cts.12688
By:
- Vishwanathan, Karthick;
- Cantarini, Mireille;
- So, Karen;
- Masson, Eric;
- Fetterolf, Jennifer;
- Ramalingam, Suresh S.;
- Harvey, R. Donald
Publication type:
Article

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