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A Phase I Dose-Finding Design Incorporating Intra-Patient Dose Escalation.
Pharm Stat
December 2024
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Conventional Phase I trial designs assign a single dose to each patient, necessitating a minimum number of patients per dose to reliably identify the maximum tolerated dose (MTD). However, in many clinical trials, such as those involving pediatric patients or patients with rare cancers, recruiting an adequate number of patients can pose challenges, limiting the applicability of standard trial designs. To address this challenge, we propose a new Phase I dose-finding design, denoted as IP-CRM, that integrates intra-patient dose escalation with the continual reassessment method (CRM).
View Article and Find Full Text PDFBiopharmaceutical and pharmacokinetic attributes to drive nanoformulations of small molecule tyrosine kinase inhibitors.
Asian J Pharm Sci
December 2024
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research Kolkata, 168, Maniktala Main Road, Kolkata 700054, West Bengal, India.
Buoyed by the discovery of small-molecule tyrosine kinase inhibitors (smTKIs), significant impact has been made in cancer chemotherapeutics. However, some of these agents still encounter off-target toxicities and suboptimal efficacies due to their inferior biopharmaceutical and/or pharmacokinetic properties. Almost all of these molecules exhibit significant inter- and intra-patient variations in plasma concentration-time profiles.
View Article and Find Full Text PDFLetter to the Editor: "Ultra-low-dose vs standard-of-care-dose CT of the chest in patients with post-COVID-19 conditions-a prospective intra-patient multi-reader study".
Eur Radiol
December 2024
Department of Radiodiagnosis & Imaging, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Reply to Letter to the Editor: "Ultra-low-dose vs. standard-of-care-dose CT of the chest in patients with post-COVID-19 conditions-a prospective intra-patient multi-reader study".
Eur Radiol
December 2024
Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria.
Safety and efficacy of a novel 0.5% epinastine topical eyelid cream in allergic conjunctivitis: a phase 3 trial.
Jpn J Ophthalmol
November 2024
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine, Tokyo, Japan.
Purpose: The high prevalence of allergic conjunctivitis in Japan necessitates novel, easy-to-use treatment options for prophylactic use. We evaluated the safety and efficacy of a newly-developed 0.5% epinastine topical eyelid cream to prevent the development of allergic conjunctivitis.
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