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Autor:
Russ Wada, Ophelia Yin, Malaz Abutarif, Frank LaCreta, Seiko Endo, Kazutaka Yoshihara, Yuan Xiong, Tushar Garimella
Publikováno v:
Clinical Pharmacology and Therapeutics
Trastuzumab deruxtecan (DS-8201) is a human epidermal growth factor receptor 2 (HER2)-targeting antibody-drug conjugate with a novel enzyme-cleavable linker, a topoisomerase I inhibitor payload, and a drug-to-antibody ratio of ≈ 8. We have characte
Publikováno v:
Clinical Pharmacology and Therapeutics
A nonlinear mixed effects modeling approach was used to conduct a model-based meta-analysis (MBMA) of longitudinal, summary-level, baseline-corrected 28-joint Disease Activity Score (ΔDAS28) clinical trial data from seven approved rheumatoid arthrit
Autor:
Lauren Horlbogen, Vu Le, Hiroyuki Kusuhara, Yuichi Sugiyama, Kenichi Furihata, Manoli Vourvahis, Sumathy Mathialagan, Linda S. Wood, Lina Luo, Takeshi Miyake, Jillian G. Johnson, Emi Kimoto, A. David Rodrigues, Ragu Ramanathan, Chieko Muto
Publikováno v:
Clinical Pharmacology and Therapeutics
Endogenous biomarkers are emerging to advance clinical drug-drug interaction (DDI) risk assessment in drug development. Twelve healthy subjects received a multidrug and toxin exclusion protein (MATE) inhibitor (pyrimethamine, 10, 25, and 75 mg) in a
Autor:
Jacqueline G Gerhart, Dan L. Stewart, Namasivayam Ambalavanan, Gregory M Sokol, Daniel Gonzalez, Matthew M. Laughon, Chi D. Hornik, Andrea N. Edginton, Sara Salerno, Mary Mills, Karen Martz
Publikováno v:
Clinical pharmacology and therapeutics
Physiologically-based pharmacokinetic (PBPK) modeling can potentially predict pediatric drug-drug interactions (DDIs) when clinical DDI data are limited. In infants for whom treatment of pulmonary hypertension and prevention or treatment of invasive
Autor:
Nieko Punt, Adriana Navarro Sainz, William Shuman, Tomoyuki Mizuno, Balaji Baskaran, Zachary L. Taylor, Nicholas Felicelli, Alexander A. Vinks, Jesper Heldrup, Laura B. Ramsey
Publikováno v:
Clinical Pharmacology and Therapeutics
Methotrexate (MTX), an antifolate, is administered at high doses to treat malignancies in children and adults. However, there is considerable interpatient variability in clearance of high-dose (HD) MTX. Patients with delayed clearance are at an incre
Autor:
Saskia N. de Wildt, Arjan de Vries, Wouter H. J. Vaes, Bianca D van Groen, Dick Tibboel, Esther van Duijn, M. G. Mooij
Publikováno v:
Clinical Pharmacology and Therapeutics, 108, 5, pp. 1003-1009
Clinical Pharmacology and Therapeutics, 108, 1003-1009
Clinical Pharmacology and Therapeutics, Epub 9 May
Clinical Pharmacology and Therapeutics, 108(5), 1003-1009. Wiley-Blackwell
Clinical Pharmacology and Therapeutics, 108, 1003-1009
Clinical Pharmacology and Therapeutics, Epub 9 May
Clinical Pharmacology and Therapeutics, 108(5), 1003-1009. Wiley-Blackwell
Growth and development affect drug-metabolizing enzyme activity thus could alter the metabolic profile of a drug. Traditional studies to create metabolite profiles and study the routes of excretion are unethical in children due to the high radioactiv
Autor:
Marietta Kollars, Jolanta M. Siller-Matula, Martin F. Wolkersdorfer, Alexandra Kaider, Paul A. Kyrle, Ludwig Traby, Sabine Eichinger, Michael Wolzt
Publikováno v:
Clinical Pharmacology and Therapeutics
Dual antiplatelet therapy (DAPT) is standard in acute coronary syndrome but confers a bleeding risk. To compare effects of clopidogrel single antiplatelet therapy (SAPT) with clopidogrel-based DAPT on hemostatic system activation we conducted a rando
Autor:
Guilherme Suarez-Kurtz
Publikováno v:
Clinical pharmacology and therapeutics. 110(3)
Plasmodium vivax (P. vivax) is the most widespread human malaria parasite, with 2.5 billion people at risk of infection worldwide. P. vivax forms liver hypnozoites, which trigger further symptomatic episodes (relapses) weeks or months after the initi
Autor:
Poulami Barman, Barbara Goodnature, Huanyao Gao, Lois E. Shepherd, Erin E. Carlson, Richard M. Weinshilboum, Matthew P. Goetz, James N. Ingle, Junmei Cairns, Krishna R. Kalari, Liewei Wang, Matthew J. Ellis, Paul E. Goss
Publikováno v:
Clinical Pharmacology and Therapeutics
Aromatase inhibitors (AIs) are the treatment of choice for hormone receptor-positive early breast cancer in postmenopausal women. None of the third-generation AIs are superior to the others in terms of efficacy. We attempted to identify genetic facto
Autor:
Deena L. Hadi, Rakshit S. Tanna, Jashvant D. Unadkat, Mary F. Paine, Nadja B. Cech, Sumit Bansal, Justina C. Calamia, Matthew E. Layton, Kenneth E. Thummel, Dan-Dan Tian, Miklós Horváth, Christopher M. Arian, Bálint Molnár, Joshua J. Kellogg, Laura M. Shireman, John R. White, James Nguyen, Richard D. Boyce
Publikováno v:
Clin Pharmacol Ther
The botanical natural product goldenseal can precipitate clinical drug interactions by inhibiting cytochrome P450 (CYP) 3A and CYP2D6. Besides P-glycoprotein, effects of goldenseal on other clinically relevant transporters remain unknown. Established