Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model‐informed Drug Development Strategy

Authors: Zahir, Hamim, Yin, Ophelia, Hsu, Ching, Wagner, Andrew J., Jiang, Jason, Wang, Xiaoning, Greenberg, Jon, Shuster, Dale E., Kakkar, Tarundeep, LaCreta, Frank

Source: Clinical pharmacology in drug development. 12(5):475-483

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100181674827.0x000001&indx=1&recIds=ETOCvdc_100181674827.0x000001

Pharmacokinetics of the Multi‐kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality

Authors: Zahir, Hamim, Greenberg, Jonathan, Hsu, Ching, Watanabe, Kengo, Makino, Chie, He, Ling, LaCreta, Frank

Source: Clinical pharmacology in drug development. 12(2):159-167

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100173056231.0x000001&indx=1&recIds=ETOCvdc_100173056231.0x000001

Effect of Mild and Moderate Hepatic Impairment (Defined by Child–Pugh Classification and National Cancer Institute Organ Dysfunction Working Group Criteria) on Pexidartinib Pharmacokinetics

Authors: Zahir, Hamim, Greenberg, Jonathan, Hsu, Ching, Marbury, Thomas C., Lasseter, Kenneth C., Xu, Li‐An, Tap, William D., Healey, John H., Stacchiotti, Silvia, LaCreta, Frank

Source: Journal of clinical pharmacology. 62(8):992-1005

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Model‐based assessments of CYP3A‐mediated drug‐drug interaction risk of milademetan

Authors: Hong, Ying, Ishizuka, Tomoko, Watanabe, Akiko, Tachibana, Masaya, Lee, Mark, Ishizuka, Hitoshi, LaCreta, Frank, Abutarif, Malaz

Source: Clinical and translational science. 14(6):2220-2230

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Apixaban Single‐Dose Pharmacokinetics, Bioavailability, Renal Clearance, and Pharmacodynamics Following Intravenous and Oral Administration

Authors: Frost, Charles, Garonzik, Samira, Shenker, Andrew, Barrett, Yu Chen, LaCreta, Frank

Source: Clinical pharmacology in drug development. 10(9):974-984

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100128260183.0x000001&indx=1&recIds=ETOCvdc_100128260183.0x000001

Exposure‐Response Relationships in Patients With HER2‐Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan

Authors: Yin, Ophelia, Iwata, Hiroji, Lin, Chia‐Chi, Tamura, Kenji, Watanabe, Junichiro, Wada, Russ, Kastrissios, Helen, AbuTarif, Malaz, Garimella, Tushar, Lee, Caleb, Zhang, Lin, Shahidi, Javad, LaCreta, Frank

Source: Clinical pharmacology & therapeutics. 110(4):986-996

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Population Pharmacokinetics of Trastuzumab Deruxtecan in Patients With HER2‐Positive Breast Cancer and Other Solid Tumors

Authors: Yin, Ophelia, Xiong, Yuan, Endo, Seiko, Yoshihara, Kazutaka, Garimella, Tushar, AbuTarif, Malaz, Wada, Russ, LaCreta, Frank

Source: Clinical pharmacology & therapeutics. 109(5):1314-1325

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100120013156.0x000001&indx=1&recIds=ETOCvdc_100120013156.0x000001

Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study

Authors: Vakkalagadda, Blisse, Lubin, Susan, Reynolds, Laurie, Liang, Dan, Marion, Alan S., LaCreta, Frank, Boulton, David W.

Source: In Clinical Therapeutics August 2016 38(8):1890-1899

Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults

Authors: Song, Yan, Chang, Ming, Suzuki, Akiyuki, Frost, Robert J.A., Kelly, Anne, LaCreta, Frank, Frost, Charles

Source: In Clinical Therapeutics July 2016 38(7):1674-1685

Fed and Fasted Single-dose Assessment of Bioequivalence of Dapagliflozin and Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects

Authors: Boulton, David W., Chang, Ming, Griffen, Steven C., Kitaura, Catia, Lubin, Susan, Pollack, Allyson, LaCreta, Frank

Source: In Clinical Therapeutics 1 January 2016 38(1):99-109

Relative Bioavailability of Apixaban Solution or Crushed Tablet Formulations Administered by Mouth or Nasogastric Tube in Healthy Subjects

Authors: Song, Yan, Wang, Xiaoli, Perlstein, Itay, Wang, Jessie, Badawy, Sherif, Frost, Charles, LaCreta, Frank

Source: In Clinical Therapeutics 1 August 2015 37(8):1703-1712

Bioequivalence, Food Effect, and Steady‐State Assessment of Dapagliflozin/Metformin Extended‐release Fixed‐dose Combination Tablets Relative to Single‐component Dapagliflozin and Metformin Extended‐release Tablets in Healthy Subjects

Authors: Chang, Ming, Liu, Xiaoni, Cui, Dapeng, Liang, Dan, LaCreta, Frank, Griffen, Steven C., Lubin, Susan, Quamina‐Edghill, Donette, Boulton, David W.

Source: In Clinical Therapeutics 1 July 2015 37(7):1517-1528

Effects of a Fixed-Dose Co-Formulation of Daclatasvir, Asunaprevir, and Beclabuvir on the Pharmacokinetics of a Cocktail of Cytochrome P450 and Drug Transporter Substrates in Healthy Subjects

Authors: Garimella, Tushar, Tao, Xiaolu, Sims, Karen, Chang, Yi-Ting, Rana, Jignasa, Myers, Elsa, Wind-Rotolo, Megan, Bhatnagar, Rahul, Eley, Timothy, LaCreta, Frank, AbuTarif, Malaz

Source: Drugs in R&D. 18(1):55-65

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UHPLC-MS/MS bioanalysis of urinary DHEA, cortisone and their hydroxylated metabolites as potential biomarkers for CYP3A-mediated drug–drug interactions

Authors: Zheng, Naiyu, Christopher, Lisa J, Ma, Xuewen, Ji, Qin C, Buzescu, Adela, Kandoussi, Hamza, Garonzik, Samira M, LaCreta, Frank, Aubry, Anne-Francoise, Arnold, Mark E, Zeng, Jianing

Source: Bioanalysis. 8(23):2429-2443

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Bioequivalence and food effect of heat-stressed and non⿿heat-stressed dapagliflozin 2.5- and 10-mg tablets

Authors: LaCreta, Frank, Griffen, Steven C., Liu, Xiaoni, Smith, Charles, Hines, Carey, Volk, Kevin, Tejwani, Ravindra, Boulton, David W.

Source: International journal of pharmaceutics. 511(1):288-295

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100065928041.0x000001&indx=1&recIds=ETOCvdc_100065928041.0x000001

Pharmacokinetic and Pharmacodynamic Properties of Single- and Multiple-Dose of Dapagliflozin, a Selective Inhibitor of SGLT2, in Healthy Chinese Subjects

Authors: Yang, Li, Li, Haiyan, Li, Hongmei, Bui, Anh, Chang, Ming, Liu, Xiaoni, Kasichayanula, Sreeneeranj, Griffen, Steven C., LaCreta, Frank P., Boulton, David W.

Source: In Clinical Therapeutics August 2013 35(8):1211-1222

Randomized, blinded, placebo‐ and positive‐controlled crossover study to determine the effect of multiple doses of apixaban on the QTc interval

Authors: Frost, Charles, Nepal, Sunil, Byon, Wonkyung, Moore, Kenneth, Reeves, Richard A., Boyd, Rebecca, LaCreta, Frank

Source: Journal of clinical pharmacology. 55(5):549-555

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100150094641.0x000001&indx=1&recIds=ETOCvdc_100150094641.0x000001

Influence of Hepatic Impairment on the Pharmacokinetics and Safety Profile of Dapagliflozin: An Open-Label, Parallel-Group, Single-Dose Study

Authors: Kasichayanula, Sreeneeranj, Liu, Xiaoni, Zhang, Weijiang, Pfister, Marc, LaCreta, Frank P., Boulton, David W.

Source: In Clinical Therapeutics 2011 33(11):1798-1808

When opportunity met aspirational goals: accelerator MS, microdosing and absolute bioavailability studies

Authors: Arnold, Mark E, LaCreta, Frank

Source: Bioanalysis. 4(15):1831-1834

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100115559772.0x000001&indx=1&recIds=ETOCvdc_100115559772.0x000001

Evaluation of Absorption and Metabolism-Based DDI Potential of Pexidartinib in Healthy Subjects.

Authors: Zahir, Hamim, Greenberg, Jonathan, Shuster, Dale, Hsu, Ching, Watanabe, Kengo, LaCreta, Frank

Source: Clinical Pharmacokinetics; Nov2022, Vol. 61 Issue 11, p1623-1639, 17p

Subject Terms: MACROPHAGE colony-stimulating factor, PHARMACOKINETICS, CYTOCHROME P-450, GIANT cell tumors, DRUG interactions, CYTOCHROME P-450 CYP3A, PROTEIN-tyrosine kinases

Geographic Terms: UNITED States