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排序方式: 共有3468条查询结果,搜索用时 15 毫秒
41.
Olivia Bonardi Yutong Wang Kexin Li Xiaowen Jiang Ankur Krishnan Chen He Ying Sun Yin Wu Jill T. Boruff Sarah Markham Danielle B. Rice Ian Thombs-Vite Amina Tasleem Tiffany Dal Santo Anneke Yao Marleine Azar Branka Agic Christine Fahim Michael S. Martin Sanjeev Sockalingam Gustavo Turecki Andrea Benedetti Brett D. Thombs 《Revue canadienne de psychiatrie》2022,67(5):336
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Rui Zhu Hubert Chen Joshua Galanter Gaohong She Fang Cai Matthew R. Durk Yixuan Zou Liuxi Chen Jane R. Kenny Shweta Vadhavkar Simon Warren Glyn Taylor Olivia Hwang Avi Eliahu Chris Wynne Ryan Owen 《CTS Clinical and Translational Science》2022,15(5):1225
Several inflammatory cytokines that promote inflammation and pathogenesis in asthma signal through the Janus kinase 1 (JAK1) pathway. This phase I, randomized, placebo‐controlled trial assessed the pharmacokinetics and safety of single and multiple ascending doses up to 15 mg twice daily for 14 days of a JAK1 inhibitor, GDC‐0214, in healthy volunteers (HVs; n = 66). Doses were administered with a dry powder, capsule‐based inhaler. An accompanying open‐label gamma scintigraphy study in HVs examined the lung deposition of a single dose of inhaled Technetium‐99m (99mTc)‐radiolabeled GDC‐0214. GDC‐0214 plasma concentrations were linear and approximately dose‐proportional after both single and multiple doses. Peak plasma concentrations occurred at 15–30 min after dosing. The mean apparent elimination half‐life ranged from 32 to 56 h across all single and multiple dose cohorts. After single and multiple doses, all adverse events were mild or moderate, and none led to treatment withdrawal. There was no clear evidence of systemic toxicity due to JAK1 inhibition, and systemic exposure was low, with plasma concentrations at least 15‐fold less than the plasma protein binding‐corrected IC50 of JAK1 at the highest dose. Scintigraphy showed that approximately 50% of the emitted dose of radiolabeled GDC‐0214 was deposited in the lungs and was distributed well to the peripheral airways. 99mTc‐radiolabeled GDC‐0214 (1 mg) exhibited a mean plasma Cmax similar to that observed in phase I at the same dose level. Overall, inhaled GDC‐0214 exhibited pharmacokinetic properties favorable for inhaled administration. Study Highlights
- WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?
- WHAT QUESTION DID THIS STUDY ADDRESS?
- WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?
- HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?
43.
Katharine Bray-French Katharina Hartman Guido Steiner Céline Marban-Doran Juliana Bessa Neil Campbell Meret Martin-Facklam Kay-Gunnar Stubenrauch Corinne Solier Thomas Singer Axel Ducret 《Journal of pharmaceutical sciences》2021,110(7):2575-2584
Biotherapeutics have revolutionized our ability to treat life-threatening diseases. Despite clinical success, the use of biotherapeutics has sometimes been limited by the immune response mounted against them in the form of anti-drug antibodies (ADAs). The multifactorial nature of immunogenicity has prevented a standardized approach for assessing this and each of the assessment methods developed so far does not exhibit high enough reliability to be used alone, due to limited predictiveness. This prompted the Roche Pharma Research and Early Development (pRED) Immunogenicity Working Group to establish an internal preclinical immunogenicity toolbox of in vitro/in vivo approaches and accompanying guidelines for a harmonized assessment and management of immunogenicity in early development. In this article, the complex factors influencing immunogenicity and their associated clinical ramifications are discussed to highlight the importance of an end-to-end approach conducted from lead optimization to clinical candidate selection. We then examine the impact of the resulting lead candidate categorization on the design and implementation of a multi-tiered ADA/immunogenicity assay strategy prior to phase I (entry into human) through early clinical development. Ultimately, the Immunogenicity Toolbox ensures that Roche pRED teams are equipped to address immunogenicity in a standardized manner, paving the way for lifesaving products with improved safety and efficacy. 相似文献
44.
Marta Revilla-Leon Kevin Frazier Juliana B. da Costa Purnima Kumar Mai-Ly Duong Sharukh Khajotia Olivia Urquhart 《Journal of the American Dental Association (1939)》2021,152(8):669-670.e2
BackgroundDentists may choose to integrate intraoral scanners (IOSs) into their practices, but there are many different IOS technologies and system generations to choose from, posing a challenge for dentists who want to invest in them.MethodsA survey of IOS use rates, advantages, satisfaction, and training was developed and deployed through Qualtrics to the 968 members of the American Dental Association Clinical Evaluators (ACE) Panel on February 19, 2021. Nonrespondents were sent reminders, and data were analyzed in SAS Version 9.4 (SAS).ResultsA total of 369 panelists responded to the survey. IOS use was split among the ACE Panel; 53% indicated they use one in their practice. The top reason respondents began using IOSs was to improve clinical efficiency (70%). Ninety percent of respondents use IOSs for single tooth-supported crowns, and 58% began using IOSs less than 4 years ago. Most users are at least mostly satisfied (91%) with the results. Among nonusers, the top reason for not using an IOS was the high level of financial investment (66%); 34% and 40% of nonusers are thinking of buying or training with IOSs in 2021, respectively.ConclusionsUptake of IOSs is split; most users are satisfied with their results, and nonusers cited financial barriers as the most common reason for not investing in one.Practical ImplicationsAs IOSs continue to penetrate the market and dentists are faced with a decision whether to invest in one, they will need guidance on how to choose the most appropriate device for their patients. 相似文献
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Fernanda Neves de Carvalho Carolina Toniolo Zenatti Danila Cassia Reis Santana Juliana Maria da Silva Juliane Cristina Oliveira dos As Katia Kisielow dos Anjos Jessica Sigari Cassia de Lima Santos Marcelle Guerra Olivia Pereira Barros Tomaz Cochemore Roberto Camargo Narciso Mario Lucio Baptista Filho 《The Brazilian journal of infectious diseases》2018
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Darcy Walworth Jayne M. Standley Amy Robertson Amy Smith Olivia Swedberg Jennifer Jarred Peyton 《Journal of neonatal nursing : JNN》2012,18(6):210-216
The purpose of the current study was to identify effects of neurodevelopmental stimulation as administered by board certified music therapists to premature infants admitted to the neonatal intensive care unit. Premature infants (N = 108) admitted and meeting inclusion criteria were included. Experimental subjects received the developmental multimodal stimulation protocol paired with live singing (n = 25) or live singing with guitar accompaniment (n = 29). The no contact control group received standard neonatal intensive care unit care (n = 54). An ANCOVA analyses with birth weight as a covariate resulted in significant main effects found for infant length of stay (p < .05). When comparing the means, differences were found between gender and types of music paired with the developmental multimodal stimulation. The results of this study suggest an increase in neurodevelopment for infants receiving developmental multimodal stimulation as hypothesized. 相似文献